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

Model Number	103426
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 complete.
Event or Problem Description
It was reported that the patient had a no external power while connected to power module and patient cable.The patient was switched to battery power to resolve alarms.The power module and patient cable were replaced with no further issues.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a no external power alarm was able to be confirmed by the customer-submitted photos of the heartmate touch.The event records table on the heartmate touch revealed power cable disconnect, low voltage, and no external power alarms between 11:08:51 and 11:12:18 on (b)(6) 2024.There did not appear to be any interruptions in the operation of the pump during these events.Multiple attempts were made to obtain log files and details regarding the cause of the alarm, but no response was received.Available information indicated that after replacement of the power module and patient cable, no further alarms were observed.Visual inspection of the returned patient cable (lot number: 1101708110) revealed that several of the pins within its 16 pin lemo connector were slightly bent.These pins included two of the pins which pertain to the negative power signals, which could have impacted the voltage supplied to the system controller.It is not known if this pin damage was present while the power module and patient cable were connected to one another, and therefore the cause of the no external power alarm cannot be conclusively determined through this analysis.The 14v patient cable assembly is manufactured by the vendor who maintains the device history records.The heartmate 3 patient handbook (section 7 ¿alarms and troubleshooting¿) covers all alarms (visual and audible) that are associated with the system controller, including no external power, and the actions to take if the alarms cannot be resolved.The heartmate 3 patient handbook (section 6 ¿caring for the equipment¿) describes how to properly care for and clean all equipment, including the system controller and its power cables.The heartmate power module instructions for use (ifu) instructs users to regularly inspect the power module, and to not use a power module that appears damaged.The heartmate power module ifu (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.The heartmate 3 patient handbook cautions the user 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 14V
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 20054389
• Report Number: 2916596-2024-05441
• Device Sequence Number: 7977410
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: (01)00813024010784(10)1101708110
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 1101708110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• 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: 99 KG
• Patient Race: White