MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP

Model Number 5120-0000

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2019

Event Type  malfunction  

Event Description

Information was received that the pump was leaking blood from the out-take outlet.The representative noticed the pump had a crack in it and was leaking from the crack.The pump was subsequently replaced and flow returned to normal.No issues were seen in the patient.The device has been returned to the manufacturer, but analysis has not been completed to date.No additional relevant information has been received to date.

Event Description

A review of the manufacturing record for the pump did not identify any deviations or non-conformities relevant to the reported issue.The pump passed air leak testing and burn-in testing during production.

Event Description

Product analysis was completed on the returned pump.The pumps appearance was normal with no cracks apparent.A leak was identified at the pump outlet/tubing interface during leak testing.The pump was thensubjected to an 18-hour functional test.No pump leakage was noted during the test.Leakage was able to be recreated by manipulating the pump outlet tubing horizontally during testing.The definitive cause of the leak initial reported though wasn't able to be determined, but was thought to be due to excessive pressure within the pump during set-up.No additional relevant information has been received to date.

• Brand Name: TANDEMHEART PUMP
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 640 alpha drive; pittsburgh PA 15238
• MDR Report Key: 8471128
• MDR Text Key: 140678564
• Report Number: 2531527-2019-00031
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Device Catalogue Number: 5120-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1