MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT; VENTRICULAR (ASSIST) BYPASS

Model Number	103426
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported, that the patient returned their system controller for functional testing at the hospital.The system controller was kept by the hospital as a backup system controller.The functional test of the system controller was done, due to safety issues because the power cable disconnect alarm was triggered.The alarm was contributed to the short circuited 14v patient cable.Related manufacturer reference number: 2916596-2023-01875 (system controller).
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a short-circuited patient cable was unable to be confirmed.The heartmate 14 volt power module patient cable (lot # 11016053104) was not returned for analysis.Per the provided information, the patient was experiencing power cable disconnect alarms.The customer determined the 14v patient cable had short-circuited.No log files, photos, or additional documents were submitted for review.A root cause for the reported event was unable to be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate iii instructions for use (ifu) section 7 - ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 - ¿alarms and troubleshooting¿ address how to properly interpret and troubleshoot all system alarms, including power cable disconnect alarms.Heartmate iii instructions for use section 3 - ¿powering the system¿ and heartmate iii patient handbook section 3 - ¿powering the system¿ states that power module preventative maintenance must be performed at least once every 12 months, which includes replacing the patient cable.The patient handbook and ifu also 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16770121
• Report Number: 2916596-2023-02366
• Device Sequence Number: 6417606
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: 00813024010784
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 103426
• Device Catalogue Number: 103426
• Device Lot Number: 11016053104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 70 KG