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

Model Number	103426
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of power cable disconnect alarms while on power module was confirmed.The evaluation of the returned 14v power module patient cable revealed several severed/opened inner wires.Two of the wires represent the rsoc (relative state of charge) and alarm out lines and two wires were not in use (spare) wires.As a result of the opened rsoc wire, the system activated the reported power cable disconnect alarm.The provided log file contained data recorded from the time stamp of day 1442, 17 hours and 13 minutes to day 1453, 14 hours and 26 minutes.There were multiple power cable disconnect alarms captured in the log file and the associated voltage levels suggested that the alarms occurred while on connected to a power module and there is a possible issue with the rsoc signal line.The root cause of the damaged inner wires appeared to be related to wear and tear due to repetitive lead flexing during cable use.The device history records could not be reviewed for the 14v patient cable due to the records being unavailable and maintained by the vendor.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that multiple power cable disconnect events were recorded while connecting to a power module at home.The power module patient cable was replaced.Log file confirmed atypical power cable disconnect events while connected to the power module.No further alarms were noted after the power module patient cable was exchanged.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of power cable disconnect alarms while on power module was confirmed.The evaluation of the returned 14v power module patient cable revealed several severed/opened inner wires.Two of the wires represent the rsoc (relative state of charge) and alarm out lines and two wires were not in use (spare) wires.As a result of the opened rsoc wire, the system activated the reported power cable disconnect alarm.The provided log file contained data recorded from the time stamp of day 1442, 17 hours and 13 minutes to day 1453, 14 hours and 26 minutes.There were multiple power cable disconnect alarms captured in the log file and the associated voltage levels suggested that the alarms occurred while on connected to a power module and there is a possible issue with the rsoc signal line.The root cause of the damaged inner wires appeared to be related to wear and tear due to repetitive lead flexing during cable use.The device history records could not be reviewed for the 14v patient cable due to the records being unavailable and maintained by the vendor.Patient handbook rev operating manual ja-jp rev.F, instructions for use 105747 ja-jp rev.B covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.The patient handbook advises the user to call the hospital contact person if there is any questions or concerns regarding the heartmate ii lvas equipment including the system controller.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: 17202252
• Report Number: 2916596-2023-03853
• Device Sequence Number: 5540810
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: 813024010784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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 Lot Number: M282250921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 48 KG