MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE; VENTRICULAR (ASSIST) BYPASS

Model Number L1340

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement for this complaint.There was no patient involved in this event.The pma# provided is associated with most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the customer found that the power module backup battery had leaked acid into the casing.The battery and battery clips were missing.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the power module backup battery had leaked acid into the casing was not confirmed, as the power module (b)(6) was not returned for analysis.It was reported that acid leakage was observed into the internal backup casing.However, no images were submitted for review.The internal backup battery and battery clips were missing as well.Multiple attempts were made to obtain additional information from the customer regarding the event, including the return status of the device; however, no additional information was provided.To date, the heartmate power module (b)(6) is unavailable for evaluation.A root cause for the reported event was not determined through this analysis.As a result, this complaint file will be close with no further action.If the product is returned at a later time, the complaint file will be re-open.Device history records were reviewed.The device was manufactured in accordance to manufacturing and quality assurance specifications.Heartmate ii power module serial number (b)(6) was shipped to the customer on 18dec2009.Heartmate ii instructions for use (ifu) and heartmate 3 ifu have details on the proper use of the power module.If the power module does not function properly, contact the company's technical service department for assistance.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE POWER MODULE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12259530
• MDR Text Key: 264513480
• Report Number: 2916596-2021-03922
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 00813024010654
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1