MAUDE Adverse Event Report: MEDTRONIC, INC CUSTOM PERFUSION SYSTEM; VENTRICULAR ASSIST DEVICE TUBING SET

Model Number BB8N60R3

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/08/2015

Event Type  malfunction  

Event Description

The patient had been on both right and left ventricular assist devices for approximately 4 days.On post-op day 4 she was taken back to operating room to clear a clot.On return to the nursing unit the patient was being repositioned in bed when the rvad tubing connection completely failed at a manufactured joint, adjacent to the 'diamond', which opened the tubing circuit to atmosphere.The patient was attended when it occurred, so staff were able to respond quickly to control bleeding.However, the patient did lose a significant amount of blood very quickly, requiring blood transfusions to correct the loss.Manufacturer response for custom perfusion system, ventricular assist device tubing set, (brand not provided) (per site reporter): our lead perfusionist contacted the manufacturer's rep.Medtronic and the rep have been very responsive and engaged in reviewing this event for us.The tubing set was released to medtronic for evaluation, with the request that they forward a written report of their evaluation.Our lead perfusionist and the medtronic rep have developed an update to our custom tubing set pack to include banding on this connection for all new tubing sets moving forward.

• Brand Name: CUSTOM PERFUSION SYSTEM
• Type of Device: VENTRICULAR ASSIST DEVICE TUBING SET
• Manufacturer (Section D): MEDTRONIC, INC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 5224899
• MDR Text Key: 31198652
• Report Number: 5224899
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BB8N60R3
• Device Catalogue Number: BB8N60R3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 86