- MedSun Adverse Events Reports
- MD Medical Product Safety Network
- Medical Devices Safety Network
- Medical Product Safety
- Adverse Event Reporting Program
- 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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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
2006-03-24 to 2020-11-04
John Snow Labs; U.S. Food and Drug Administration (FDA);
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Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting
MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network
|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||-|
|Device Brand||Device Manufacturer||Device Type||Device Problem||Date Report||Event Description|
|Homograft||CRYOLIFE INC.||Heart Valve More Than Minimally Manipulated Allograft||Serious injury;Death||2021-05-06||Female who is postoperative day 4 following extensive repair of a para visceral mycotic aneurysm with distal descending thoracic to distal abdominal aortic cryopreserved graft through a left thoracotomy and left retroperitoneal approach as well as retrograde de branching of the renal arteries as well as the superior mesenteric artery. She actually tolerated the procedure very well and was making an excellent postoperative recovery. This evening she developed acute arterial hemorrhage emanating from the retroperitoneal drain as well as hypotension and abdominal distention. She was resuscitated in the ICU and emergently brought down to the operating room. While resuscitation was ongoing the patient was placed in right lateral decubitus position on a beanbag and prepped and draped in a sterile manner from the level of the shoulder to the knees. Administration of preoperative antibiotic was confirmed - and a procedural pause was quickly observed. The left retroperitoneal incision was quickly opened - and a large volume of arterial blood and clots was evacuated. At this stage the patient became profoundly hypotensive and a Fogarty Hydragrip clamp was quickly placed on the abdominal segment of the thoracic aorta to abdominal aortic cryopreserved graft. It soon became evident that the bleeding was coming from a significant sized hole that had developed on the anterior wall of the distal aorta aortic cryopreserved graft. There was no hemorrhage from any of the suture lines or any of the other de branching graft. This was repaired with continuous pledgeted 5-0 Prolene utilizing bovine pericardium as pledgets given the weak wall of the cryopreserved graft while intermittently CPR was being administered. Findings 1. Large volume arterial blood and clot evacuated from the retroperitoneal wound upon reopening. 2.Acute - profuse hemorrhage from 0.75 cm hole anterior wall of distal aspect thoracic to distal abdominal aortic composite cryopreserved bypass graft. This case was substantially more difficult than usual because of significant effort and difficulty mobilizing and identifying anatomical structures due to altered surgical field secondary to previous surgery and tissue friability. This case was substantially more difficult than usual because of prolonged/ significant intra-operative hemorrhage. This case was substantially more difficult than usual because of serious medical condition(s) of the patient. Complications Death|
|Clydesdale Spinal System||MEDTRONIC SOFAMOR DANEK INC.||Intervertebral fusion device with bone graft lumbar||Potential for patient harm||2021-05-06||Neurosurgeon was placing implant at L4-5 when the cage broke. He used a long curette to try and extract the implant - and the tip broke off into the patient's disc space. The broken cage and tip of curette were removed from the patient with no obvious harm.|
|THERMOCOOL SMARTTOUCH SF||BIOSENSE WEBSTER INC.||Cardiac ablation percutaneous catheter||Potential for patient harm||2021-05-04||Temperature sensor not working - changed out for a new catheter without problem PC-000902584.|
|EndoWrist||INTUITIVE SURGICAL INC.||Systemsurgicalcomputer controlled instrument||Potential for patient harm||2021-05-04||During routine use - the wire snapped at the end of the mega needle driver.|
|Medichoice Polyisoprene Surgical Gloves (Distributed by Owens and Minor)||ANSELL HEALTHCARE PRODUCTS LLC||Surgeon's Gloves||Potential for patient harm||2021-05-03||Patient underwent cataract surgery and developed Toxic Anterior Segment Syndrome (TASS) post procedure. Surgical Technician and Surgeon noticed a difference in texture of the surgical gloves used in this particular case. The difference in texture raised concerns of surgical gloves possibly containing a powdered substance. The gloves in question are MediChoice Polyisoprene Surgical gloves REF #SGL95085 with a lot number 2010525704. All Gloves with this specific lot number were pulled from the Operating Room and isolated.|
|Transonic||TRANSONIC SYSTEMS INC.||Flowmeter Blood Cardiovascular||Potential for patient harm||2021-04-30||No low flow alarms triggered by R IJ ECMO flow probe. Alarm Issues: Alarm Set Incorrectly. Prior to event - stable R IJ ECMO flows >1.3 and stable L groin ECMO > 4.4 noted during morning handoff report with PM RN and during pre-rounds with ALD resident. Around 0845 - No flow on R IJ ECMO Cannula visually noticed with Anesthesiologist during ICU Rounds - no alarms at this time. Perfusionist assessed and reported seeing separation of blood/clot in R IJ cannula. Patient has a known Atrial Septal Defect (ASD). Throughout the event patient was hemodynamically stable and intact mental status. Emergent removal of R IJ cannula performed bedside by MD. Patient received 30mcg epinephrine IV push for cardiac support and 125mcg of fentanyl. Patient hemodynamically tolerated the decannulation. Low flow alarm or no flow alarm would have been useful in this situation.|
|LigaSure||Covidien LP||Electrosurgical cutting coagulation accessories||Not applicable;Potential for patient harm||2021-04-30||Blunt tip LigaSure from kidney pack numerous times stated error message on the LigaSure machine which stated incomplete seal cycle; Replaced handpiece. Hand piece placed in Operating QA office. Follow-up with Medtronic. Procedure: Donor Nephrectomy.|
|Diagnostic EP Catheter FJ 7F||STRYKER SUSTAINABILITY SOLUTIONS INC.||CATHETER RECORDING ELECTRODE REPROCESSED||Potential for patient harm||2021-04-30||Deflective mechanism not working on reprocessed CS (coronary sinus) catheter - removed from body and a new catheter inserted.|
|ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP||INFUTRONIX LLC||Set Administration Intravascular||Potential for patient harm;Minor injury to the patient or health care provider||2021-04-29||Patient was bolused via tubing of Nimbus. When disconnecting extension tubing the Nimbus tubing cracked. The decision was made to discontinue the the block. Pain control plan was discussed with primary team. Initial placement was done with Ultrasound guidance and was successful and uneventful.|
|CADD Medication Casstte||SMITHS MEDICAL MD INC.||Set administration intravascular||Not known;Potential for patient harm||2021-04-29||Patient was connected to an ambulatory infusion pump (CADD) containing chemotherapy (5FU). Patient reported to Cancer Center for anticipated disconnection. Patient reported CADD pump alarmed that the infusion was complete 4 hours before it was scheduled to be completed. Patient called MD on call between 6 am & 7 am and was advised to come to the Cancer Ctr. when it opened at 9 am. When patient arrived - the pump stated patient received 78 ml and that 12 ml remains to be infused - but the medication bag was completely collapsed / empty. Subsequently we have had similar cases reported by 7 other patients. We have pulled all of the affected pumps from service and are working with Infusystem (Pump manufacturer) and Smiths Medical (cassette / tubing manufacturer) to trouble shoot and find a resolution to this problem.|