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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 | 2024-06-13 |
| Version | 2024-06-13 |
| Update Frequency |
Daily |
| Temporal Coverage |
2006-03-24 to 2024-06-13 |
| 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 |
| CLEARLINK/CONTINU-FLO | BAXTER HEALTHCARE CORPORATION | Set administration intravascular | Serious injury | 2024-07-16 | Event #1 [redacted date] Situation: Leaking Baxter tubing. Background: Ongoing issues with leaking Baxter tubing. Assessment: This author was performing daily central line audits and noted a Y-site port of the Baxter tubing running TPN and a Y-site port of the Baxter tubing running lipids - leaking despite green alcohol cap being in place. Y-sites marked with tape to indicate where leak was. Orders placed to hang clear fluids to replace leaking tubing - which bedside RN will do per NNICU protocol once fluids arrive. Lot number unknown. Tubing will be saved and given to APSM. Recommendation: Continue to work with Baxter on solution to avoid depriving infants of necessary nutrition. Event #2 [redacted date] Situation: Leaking Baxter tubing. Background: Ongoing issues with leaking Baxter tubing. Assessment: This author was performing daily central line audits and noted a Y-site port of the Baxter tubing running lipids leaking despite green alcohol cap being in place. Y-site marked with tape to indicate where leak was. Orders placed to hang clear fluids to replace leaking tubing - which bedside RN will do per NNICU protocol once fluids arrive. Lot number unknown. Tubing will be saved and given to APSM. Recommendation: Continue to work with Baxter on solution to avoid depriving infants of necessary nutrition. Event #3 [redacted date] Patient has a central line running TPN via Baxter tubing. One of the Y-sites on the Baxter tubing closest to the filter was found to be leaking into the green cap. TPN was discarded and new fluids were hung. Event #4 [redacted date] Baxter tubing noted to have leak around green cap at Y-site before filter. Sent to materials. Manufacturer response for IV Tubing - (brand not provided) (per site reporter) Meeting with Baxter every other week on this issue which has been occurring since February 2022. |
| EndoFLIP | Covidien | System Gastrointestinal Motility (Electrical) | Not applicable | 2024-07-12 | There was no injury to the patient. After passing initial testing - at the time of use the catheter was unable to provide pressure. |
| ENDOPOUCH RETRIEVER | ETHICON ENDO-SURGERY LLC | Laparoscope general plastic surgery | Not applicable | 2024-07-11 | From Staff: Bag endo retrieval pouch was defective after opening at the field. It was not used on the patient and never touched the patient. It was defective upon removal from packaging. |
| BOVIE | Symmetry Surgical Inc. | Cautery High Temp Fine Tip | Not applicable | 2024-07-11 | From Staff: During a pediatric surgery - the patient was masked down for a lysis of penile adhesion. When the surgeon used the cautery high temp fine tip Bovie it took a minute to activate and heat up. Once it warmed up enough - the surgeon started the procedure. The First Assist student noticed the raytec sponge in their hand started turning black and felt warm. They placed the raytec on the mayo stand and an ember formed and caught on fire. The surgical tech tossed the raytec on the floor to avoid further spread. The fire was them put out safely with no harm to the patient or others. |
| LINQ II LNQ22 | MEDTRONIC INC. | Recorder event implantable cardiac (with arrhythmia detection) | Serious injury | 2024-07-11 | Issue #1 FAILURE TO GENERATE REPORTS [redacted name] Heart and Vascular (HVC) Remote Patient Monitoring (RPM) team follows a total of 7674 active patients with cardiac implanted electronic devices (CIEDs) - consisting of pacemakers - Implantable cardioverter-defibrillator (ICDs) and Implantable loop recorders (ILRs). 1058 of these patients have ILRs - of which 99% are Medtronic devices. Unlike pacers and ICDs - which deliver therapy to the patient - the sole purpose of the ILR device is to monitor patients. Patient monitoring occurs initially through a vendor run website. Medtronic uses a system it calls âCarelinkâ. Carelink provides monitoring information about the devices to our clinics. They provide the information in two ways. Firstly - they provide monthly reports for each patient. In addition - they provide more immediate information should a patient develop a symptom or should the device find an abnormal reading (i.e. - a significant pause - ventricular tachycardia - atrial fibrillation). These alerts are provided on a daily basis. [redacted name] contacts all patients who send a transmission due to a symptom - to further assess these patients. [redacted name] has set up alert parameters based on vendor recommendation but have turned all patient activated alerts on - so that we can call and assess patients whether there is an associated arrhythmia or not. When a patient undergoes ILR implant - we immediately have the patient send a âsymptom transmissionâ - to be sure that the system is functioning properly. Once we have confirmed âconnectivityâ - the patient is enrolled in our remote monitoring clinic and educated on the system and how to stay âconnectedâ. Ensuring that the patients remain connected to our clinic is a major initiative of our clinic. As long as a patient is connected - all alerts (either patient symptoms or automatically detected arrhythmias) are transmitted to Carelink and generate a report once daily (early morning). These reports are not generated in âreal timeâ. The clinic staff reviews these alerts daily and contacts all symptomatic patients as appropriate. In addition - Medtronic ILRs generate a monthly report (a âsummary reportâ). This report summarizes all activity for the previous month (battery status - arrhythmias detected - symptoms). This report is also reviewed by the clinic staff. Based on the [redacted name] workflow - there should never be an alert that appears on the monthly report that was not previously reported as a âdaily alertâ. Over the last several months - the remote monitoring staff has begun to see alerts appear on the monthly report that had not been reported previously - as a daily alert. ISSUE #2 Failed export transmissions [redacted name] has entered into a contractual agreement with a third party vendor - 91Life. The basic concept of the contract is that we give 91Life permission to enter all of our Vendor websites (primarily Medtronic - Boston Scientific and Abbott). Using shared technology - 91Life is able to collect the information from the vendors about our patients and generate a universal report for each patient. By reviewing this report - we are able to more efficiently care for our patients. This system has greatly streamlined our operations and improved patient care. Since the inception of the project - in 2019 - [redacted name] has struggled with âfailed exportsâ. In a failed export - the data would not automatically travel from the vendor to 91 - as designed. This has only occurred with Medtronic Carelink. No other vendors have suffered a similar difficulty with 91. When a failed report occurs - we have created a backup procedure (using [redacted name] Staff) to make sure that no data fails to get from Carelink to 91Life. It has been a longstanding issue - solely with Medtronic. As an example - one of these reports demonstrated a significant pause. We did pick up the issue - but there was a delay in care - due largely to the failed export. To date - we have adjudicated approximately 2 -500 failed transmissions. There have been 2 -494 Medtronic transmissions within [redacted name] -HVC that were manually downloaded from the manufacturer portal. For one location - there were 435 failed Medtronic exports requiring manual download from going directly into the Medtronic Carelink System. Manufacturer response for Implanatble Loop recorders - LNQ22 LINQ II (per site reporter) Have been working with them on a monthly (or more often) basis to address the problems. |
| CADD Solis | Smiths Medical ASD Inc. | Pump infusion pca | Potential for patient harm | 2024-07-11 | CADD pump was infusing medication for two days and when the pump was discontinued large discrepancy in amount remining on the pump vs the actual amount that was wasted. Concerns that patient was not receiving medication accurately for two days. |
| Perifix | B. Braun Medical Inc. | Epidural anesthesia kit | Not applicable | 2024-07-09 | Debris found in epidural anesthesia tray by anesthesiologist |
| Warming Cabinet | Getinge IC Production Poland Sp. | warmer irrigation solution | Minor injury to the patient or health care provider | 2024-07-09 | Staff was stacking blankets in blanket warmer. When they got to the top - their right thumb hit the bottom of the middle shelf of the blanket warmer. This caused a cut that bled for approximately an hour. The cut required steri-strips to close. The root cause of the injury is as follows. There are holes in the shelf for air circulation that the bottom of these holes have sharp edges. There has been previous injuries that have been caused by these sharp edges. There was a previous MedWatch for a similar Getinge Warmer - 0504540000-2021-8022. ====================== Manufacturer response for Warming Cabinet - Warming Cabinet (per site reporter) ====================== Per Clinical Engineering Technician previously involved - there were a few shelves sent however - there were sharp edges on a number of those sent. |
| Heartmate 2 | ABBOTT LABORATORIES | Ventricular (Assisst) Bypass | Death | 2024-07-09 | The patient presented to an outside hospital in cardiogenic shock. He was transferred to [redacted name] on [redacted date]. The basis of the shock was thought to be mainly attributed to thrombus within LVAD outflow graft along with likely external compression. There was no evidence of bleeding - PE (Pulmonary Embolism) of CT-PE or significant hypovolemia. The condition worsened during the hospital course with high dose pressor requirement with evidence of multi-organ injury. The patient's INR was 4.4 upon admission and remained high throughout the hospital course. The risk of surgical intervention to relieve/remove the outflow obstruction was thought to outweigh its benefits. The patient transitioned to CMO (Comfort Measures Only) and passed peacefully with family at bedside. |
| GORE VIABAHN VBX Balloon Expandable Endo | W. L. Gore & Associates Inc. | Iliac covered stent arterial | Potential for patient harm | 2024-07-03 | No injury to patient at this time. After the VBX stent was deployed - MD was pulling the stent out of the patient over the wire when the VBX port broke off from the catheter. The MD was able to pull out the rest of the stent catheter. |