BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    MDR report key: 4163528 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01139
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER MODULE PATIENT CABLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED 12 VOLT POWER MODULE PATIENT CABLE WAS CONNECTED TO THE TEST EQUIPMENT IN THE MANUFACTURER'S LAB. THE REPORT OF A RED HEART ALARM WAS CONFIRMED BASED ON THE ANALYSIS OF THE SUBMITTED LOG FILE. THE EVALUATION OF THE RETURNED POWER MODULE PATIENT CABLE REVEALED ONE BROKEN PIN WITHIN THE WHITE POWER LEMO CONNECTOR AND COMPROMISED INTERNAL CONDUCTORS IN THE BLACK AND THE WHITE POWER LEADS. THE ANALYSIS OF THE BROKEN PIN WITHIN WHITE CONNECTOR DID NOT AFFECT THE FUNCTIONALITY OF THE SYSTEM TO SUPPORT PUMP OPERATION. THE BROKEN PIN WAS RELATED TO A MISALIGNMENT ISSUE BETWEEN THE PATIENT CABLE AND THE SYSTEM CONTROLLER POWER CONNECTORS UPON PHYSICALLY MATING THE CONNECTION PARTS. THE COMPROMISED INTERNAL CONDUCTORS CONTRIBUTED TO A HIGH RESISTANCE VARIATION ACROSS THE CABLE RESULTING IN A REDUCED VOLTAGE SUPPLY TO THE SYSTEM CONTROLLER RESULTING IN THE LOW VOLTAGE (HAZARD) ALARMS DURING THE CABLE EVALUATION. THE HIGH IMPEDANCE RESISTANCE WITHIN THE CABLE'S POWER LEADS COULD POTENTIALLY RESULT IN THE HAZARD CONDITION EVENTS RECORDED IN THE LOG FILE. THE ROOT CAUSE OF COMPROMISED INTERNAL CONDUCTORS COULD BE RELATED TO WEAR AND TEAR DUE TO REPETITIVE FLEXING OF THE LEADS DURING CABLE USE. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE QUALITY ASSURANCE SPECIFICATIONS UPON SHIPMENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    USAGE OF THE DEVICE. THE USAGE OF THE DEVICE IS NOT KNOWN TO THE MANUFACTURER AS THE POWER MODULE PT CABLE IS NOT LABELED OR SINGLE USE. THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE HOSPITAL REPORTED THAT THE PT CABLE WAS EXCHANGED AND WILL BE RETURNED TO THE MANUFACTURER FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    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 HAD BEEN SLEEPING AND STOOD UP TO USE THE RESTROOM WHILE TETHERED AND EXPERIENCED A RED HEART ALARM. THE DATA LOG FILE OBTAINED BY THE MANUFACTURER CONTAINED MANY LOW VOLTAGE HAZARD ALARMS WHICH WERE CAPTURED WHEN THE PT WAS CONNECTED TO THE PT CABLE. IN ADDITION, THERE WERE 2 COMPLETE POWER LOSSES WHICH RESET THE INTERNAL CLOCK TO ZERO, ALSO WHILE THE PT WAS CONNECTED TO THE PT CABLE. THERE WAS NO INDICATION OF A DRIVELINE ISSUE. IT WAS RECOMMENDED THAT THEY REPLACE THE PT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419052 HEARTMATE 14V POWER MODULE PATIENT CABLE DSQ: POWER MODULE PATIENT CABLE (14V) DSQ THORATEC CORP. 103426 3462657039

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention