Demos
Others titles
- MedSun Adverse Events Reports
- MD Medical Product Safety Network
- Medical Devices Safety Network
Keywords
- Medical Product Safety
- Adverse Event Reporting Program
- MedSun
- MD Safety
- MD Reporting
Medical Product Safety Network
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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Description
The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.
The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.
About this Dataset
Data Info
| Date Created | 2002 |
|---|---|
| Last Modified | 2024-04-04 |
| Version | 2024-04-04 |
| Update Frequency |
Daily |
| Temporal Coverage |
2006-03-24 to 2024-04-04 |
| Spatial Coverage |
United States |
| Source | John Snow Labs; U.S. Food and Drug Administration (FDA); |
| Source License URL | |
| Source License Requirements |
N/A |
| Source Citation |
N/A |
| Keywords | Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting |
| Other Titles | MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network |
Data Fields
| Name | Description | Type | Constraints |
|---|---|---|---|
| Device_Brand | The brand of medical device | string | - |
| Device_Manufacturer | Device manufacturer name | string | - |
| Device_Type | The type of medical device | string | - |
| Device_Problem | Problem associated with the device | string | - |
| Date_Report | The Date report | date | required : 1 |
| Event_Description | The Event description | string | - |
Data Preview
| Device Brand | Device Manufacturer | Device Type | Device Problem | Date Report | Event Description |
| Echelon Contour Curved Cutter | Ethicon Endo-Surgery LLC | Staple implantable | Serious injury | 2024-04-04 | Contour stapler failed. Stapler pushers were down - but there were no staples applied. |
| PRISMAFLEX SET | GAMBRO INDUSTRIES | Dialyzer high permeability with or without sealed dialysate system | Potential for patient harm | 2024-04-04 | The patient was to start a continuous renal replacement therapy (CRRT) - and the registered nurse (RN) had attempted to start on patient and there was an issue with previous Prismaflex set. The RN set-up new Prismaflex set - and the set was connected to patient to begin therapy. The therapy was started and immediately the RN received an alarm for blood leak. The RN was able to stop therapy because the blood leak was visible in the tubing and extended to auto-effluent tubing. The patient was safely disconnected from the Prismaflex. The Prismaflex set was removed - and the Prismaflex machine was removed from service to be checked by BioMed. The patient had CRRT set-up with a new Prismaflex machine and Prismaflex set. |
| PRISMAFLEX SET | GAMBRO INDUSTRIES | Dialyzer high permeability with or without sealed dialysate system | Potential for patient harm | 2024-04-04 | Continuous renal replacement therapy (CRRT) was being setup with the Baxter Prismaflex machine. The registered nurse (RN) was following the onscreen instructions to load - prime and ready system for connection to patient to begin therapy. The Prismaflex machine has four small pumps the dialysis cassette tubing wraps around. The RN was attempting to load the tubing and the tubing would not load around the dialysate pump (upper right pump). The RN stated the tubing kept getting kinked. Finally - the tubing did load around the dialysate pump. The RN proceeded to the priming step and there was an occlusion alarm on the auto effluent tubing. The RN attempted to trouble shoot and eventually unloaded cassette and started the process again with a new cassette. |
| CLEARLINK/CONTINU-FLO | BAXTER INTERNATIONAL INC. | Set administration intravascular | Potential harm to a health care provider;Serious injury | 2024-03-28 | Leaky Baxter tubing - lot number R23A10154. Alcohol-impregnated caps have been placed on the y-sites of the tubing that have been leaking in our units. TPN running and leaking outside of the green alcohol cap. Manufacturer response for IV Tubing - (brand not provided) (per site reporter) Weekly meetings with [redacted name] and neonatal ICU teams as well now. They have offered a substitute product due to increasing number of leaks in our 2R8546 model. |
| L-Cath⢠S/L PICC S/L | ARGON MEDICAL DEVICES INC. | CatheterIntravascularTherapeuticLong-Term Greater Than 30 Days | Not applicable | 2024-03-28 | Registered Nurse Transport Specialist (RNTS) called to bedside to remove 1.9Fr peripherally inserted central catheter (PICC) line. Line inserted at the ankle saphenous vein of the right leg. RNTS confirmed the PICC removal order. RNTS stopped IVF once at bedside and dressing removed using adhesive remover. Placing a small Chloroprep wand over the insertion site - RNTS began to slowly pull back on the PICC line. Several centimeters were easily pulled back. RNTS noted that line did not full remove and attempted to pull line out again. PICC line snapped near insertion site. RNTS held fingers tightly around leg to act as a tourniquet. RNTS removed Chloroprep wand slowly to reveal <0.25cm of PICC line out of insertion site. RNTS attempted to grab end using forceps but line slipped beneath skin at insertion site. Bedside RN immediately notified NNP (Neonatal Nurse Practitioner) who came to bedside and ordered stat x-rays. Tibia/Fibula (Tib-Fib) and kidney - ureter - and bladder (KUB) x-ray done to show PICC line between knee and pelvis. Approximately 10cm of line remains. Per the advise of VAD (Vascular Access Department) - a loose tourniquet was placed around the patients thigh to help hold line in place. RNTS applied light band without compromising perfusion to leg. NNP reached out to IR (Interventional radiology). During removal - PICC line snapped only allowing half of the line to be removed. With 7cm of the line remaining in patient requiring IR removal under anesthesia. Neonatal team have reached out to Argon directly to identify any issues with their product as this seems to be a trend with their PICC lines. Removed portion of PICC line in RNTS office - remainder was discarded. This event was reported to CDPH as retention of a foreign object following surgery or procedure. |
| ARROW | TELEFLEX INCORPORATED | Catheter percutaneous | Serious injury | 2024-03-27 | This patient had known - severe calcification of the femoral arteries. On a recent catheterization - sheath removal was also complex. The interventional team elected to use the Arrow braided sheath to reinforce the stability and integrity of the access for this procedure - which was appropriate. The team was at the bedside removing the femoral sheath when a unique situation transpired - where the sheath hub detached from the shaft of the sheath. The shaft of the sheath remained in the patient and the patient began to lose blood in a pulsatile fashion from this location. Pressure was held. The patient briefly became unresponsive and was given 1 amp Epinephrine. Vascular surgery was called to the bedside and was able to retrieve the sheath. Manual pressure was held for approximately 40 minutes. The patient was given 2 units of PRBCs and was started on Levophed. The patient was transferred to the CCU for close monitoring. We have not previously seen this situation occur at MGH - and it clearly represents a manufacturing fallibility in the sheath - rather than a user error or inappropriate usage. The team removing the sheath is very experienced in sheath removal. |
| Linear 7.5Fr. 34cc IAB with Accessories US Only | DATASCOPE CORP. | System Balloon Intra-Aortic And Control | Serious injury | 2024-03-26 | Blood was noted in left axillary intra-aortic balloon pump (IABP) helium sheath after patient turned onto her left side. Blood found in the balloon. Immediate pain and paresthesia to left lower extremity - Vascular Surgery consulted - patient went to the Operating Room for left axillary artery repair and hematoma removal. |
| OCS Heart System | TRANSMEDICS INC. | Organ Care System (Ocs) Heart System | Potential for patient harm | 2024-03-26 | A donor heart was accepted for a hospital recipient. The transplant team used TransMedics Heart Organ Care System (OCS) to procure the heart. The heart procurement proceeded as normal however - it was noted that the compliance chamber of the TransMedics Heart OCS was getting larger than normal when they were priming the system. There was also a persistent air bubble that appeared next to the blood warmer. As a result - the heart could not be placed on the TransMedics Organ Care System and therefore the heart was rendered unusable for transplant due to the inability to be perfuse on the TransMedics device. This event did not cause death nor serious injury as the recipient remained on the heart transplant wait-list and was transplanted later - with a different organ. However - it rendered a heart that would have been used for transplant - unusable. The transplant team worked with TransMedics to understand the root cause of the problem and it was noted that there was a kink in the pulmonary artery (PA) tubing causing the aforementioned issues. ====================== Manufacturer response for Organ Care System - TransMedics Heart Organ Care System (per site reporter) ====================== Per TransMedics representative - they have identified the failure mode and have planned design modifications as a corrective action. The perfusion module was returned to TransMedics. Inspection of the returned perfusion module noted there was a kink in the PA (Pulmonary Artery) tubing line. The module was filled with water and was cycled. The engorged compliance chamber and air bubble near the blood warmer were replicated. When the kink in the PA tubing line was relieved - the air bubble was able to pass and the compliance chamber returned to a normal volume. Based on our analysis - we concluded that the direct root cause of the observed problems was due to the kink in the PA tubing. We are still investigating the underlying cause of the kink. |
| Philips PIIC IX Rev C PIIC IX Rev 4 | Philips North America LLC | MONITOR PHYSIOLOGICAL PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Potential for patient harm | 2024-03-22 | UPS (uninterruptible power supply) which are located in data closets that power central patient monitoring have failed across the Hospital. These failures have impacted patient care by the loss of central monitoring across multiple critical care floors. The hospital is reporting 14 failures out of approximately 22 units that were placed into the [redacted name] building within the past 10 months. These UPS devices are under warranty and are manufactured by Schneider while being distributed by Philips Healthcare. They were placed into service using the same purchase order and ordering date. [redacted name] has engaged Philips and they have replaced each UPS under the 1 year warranty - however - [redacted name] has requested that Philips Healthcare proactively replace the UPS units before failure. Philips has not acted upon the request and would prefer that the UPS units first fail before being replaced. UPDATE [redacted date] Since the original submission - 1 UPS failure occurred on the weekend of [redacted date] which took out all patient monitoring on [redacted name] North and South. Another 1 UPS failure occurred on [redacted date] which took out all patient monitoring on [redacted name] North and South. The hospital still has a UPS failure occurring - on average - every 3 weeks. The hospital expects this rate to continue until all affected units are replaced. The direct result of this is a systemic continued loss of all patient monitoring across inpatient and ICU floors. UPDATE [redacted date] Philips was onsite on [redacted date] and during their field work - there was another UPS failure that was located on one of [redacted name] 3's distribution pairs. The redundancy to the distribution pairs allowed for no loss of patient monitoring. Also - due to redundancy of distribution pairs - unable to determine when the unit specifically failed. Biomed identifying stickers indicate this unit went into use [redacted date]. |
| Philips PIIC IX Rev C PIIC IX Rev 4 | Philips North America LLC | MONITOR PHYSIOLOGICAL PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Potential for patient harm | 2024-03-21 | UPS (uninterruptible power supply) which are located in data closets that power central patient monitoring have failed across the Hospital. These failures have impacted patient care by the loss of central monitoring across multiple critical care floors. The hospital is reporting 14 failures out of approximately 22 units that were placed into the [redacted name] building within the past 10 months. These UPS devices are under warranty and are manufactured by Schneider while being distributed by Philips Healthcare. They were placed into service using the same purchase order and ordering date. [redacted name] has engaged Philips and they have replaced each UPS under the 1 year warranty - however - [redacted name] has requested that Philips Healthcare proactively replace the UPS units before failure. Philips has not acted upon the request and would prefer that the UPS units first fail before being replaced. UPDATE [redacted date] Since the original submission - 1 UPS failure occurred on the weekend of [redacted date] which took out all patient monitoring on [redacted name] North and South. Another 1 UPS failure occurred on [redacted date] which took out all patient monitoring on [redacted name] North and South. The hospital still has a UPS failure occurring - on average - every 3 weeks. The hospital expects this rate to continue until all affected units are replaced. The direct result of this is a systemic continued loss of all patient monitoring across inpatient and ICU floors. |