BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 14V POWER MODULE PT CABLE

    MDR report key: 4222472 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01807
    Event Type
    Death
    Date Received
    October 31, 2014
    Date of Event
    May 30, 2014
    Report Date
    October 2, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MFR DATE WAS ESTIMATED. THE REPORT OF A "NOT CONNECTED" MESSAGE WITH A CONTINUOUS HAZARD TONE WHILE A TEST SYSTEM CONTROLLER WAS ONLY CONNECTED TO THE WHITE POWER LEAD OF THE 14 VOLT POWER MODULE PT CABLE WAS CONFIRMED. THE ANALYSIS OF THE RETURNED 14 VOLT POWER MODULE PT CABLE FOUND A BENT PIN IN THE 16-PIN CONNECTOR WHICH CONTRIBUTED TO NOTICABLE RESISTANCE WHEN MATED TO THE RECEPTACLE OF THE TEST POWER MODULE AND THE CONNECTION WAS NOT ABLE TO BE COMPLETED. THE RETURNED 14 VOLT POWER MODULE PT CABLE WAS TESTED TOGETHER WITH THE MFR'S LAB TEST EQUIPMENT AND THE BENT PIN IN THE 16-PIN CONNECTOR PREVENTED A FULLY SEATED CONNECTION WITHIN THE RECEPTACLE RESULTING IN A LOSS OF POWER / PUMP STOPPAGE AND A CONTINUOUS HAZARD TONE WHEN THE SYSTEM WAS SUPPORTED SOLELY BY THE WHITE POWER LEAD. THE LOSS OF POWER IS CONSISTED WITH THE DATE CAPTURED IN THE LOG FILE THAT WAS RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER SERIAL NUMBER (B)(4) ASSOCIATED WITH THIS EVENT. THE ANALYSIS OF THE 16-PIN CONNECTOR INDICATES THAT THE BENT CONDITION OF PIN WAS POSSIBLY DUE TO A MISALIGNMENT ISSUE BETWEEN THE POWER MODULE PT CABLE AND POWER MODULE UPON PHYSICALLY MATING THE CONNECTOR TO THE RECEPTACLE, COMPROMISING THE ELECTRO-MECHANICAL CONNECTION OF THE POWER LINES IN THE WHITE POWER LEAD. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING THIS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED THE PT'S WIFE FOUND THE PT DOWN, COLD, AND WITH CONTINUOUS ALARM FROM THE LVAD. WHEN EMS ARRIVED, IT WAS REPORTED THAT THE PT WAS CONNECTED TO THE POWER MODULE VIA THE WHITE PT CABLE BUT NOT THE BLACK PT CABLE. THE DRIVELINE WAS FULLY CONNECTED TO THE SYSTEM CONTROLLER. THE DISPLAY MODULE WAS READING "NOT CONNECTED". EMS RECONNECTED THE BLACK PT CABLE AND THE ALARM STOPPED. PT WAS PRONOUNCED DEAD AND DEVICE SUPPORT WAS DISCONTINUED. DURING THE MFR'S INVESTIGATION, IT WAS CONFIRMED THAT THE REPORTED EVENT WAS RELATED TO THE 14 VOLT POWER MODULE PT CABLE. REF THE MFR'S MEDWATCH # 0002916596-2014-01422 FOR THE PRIMARY SYSTEM CONTROLLER, SERIAL # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697907 HEARTMATE 14V POWER MODULE PT CABLE DSQ: POWER MODULE PT CABLE DSQ THORATEC CORP. 103426 34756240210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death HEARTMATE II SYSTEM CONTROLLER, SERIAL # (B)(4)