MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 12 VOLT NIMH BATTERY CLIP SET; VENTRICULAR (ASSISST) BYPASS

Model Number	2265
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that a pin in the battery clip was bent.The battery clip was exchanged.
Additional Manufacturer Narrative
Section d4: the device lot number was requested but not provided.Section g3: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: the evaluation did not confirm the reported event of a bent pin within the battery clip.The customer exchanged the battery clip; however, the clip will not be returned for evaluation, as it was disposed of.No pictures were provided.As a result, the root cause of the reported event could not be conclusively determined, and the complaint file will close accordingly.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate3 instructions for use section 3, ¿powering the system¿ and heartmate3 patient handbook section 3, ¿powering the system¿ explain how to properly attach and tighten the power cables to the battery clip.The heartmate3 instructions for use section 7 ¿alarms and troubleshooting¿ and the heartmate3 patient handbook section 5 ¿alarms and troubleshooting¿ addresses how to interpret and troubleshoot alarms, such as power cable disconnect alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 12 VOLT NIMH BATTERY CLIP SET
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11845401
• Report Number: 2916596-2021-02770
• Device Sequence Number: 2940073
• Product Code: DSQ
• UDI-Device Identifier: 00813024010722
• UDI-Public: 813024010722
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P060054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1