BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 12454140 · Received September 10, 2021

    Report

    Report Number
    2916596-2021-04775
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 21, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF A DAMAGED MPU PATIENT CABLE, WAS CONFIRMED WHEN THE UNIT WAS EVALUATED BY DEPOT SERVICES. THE RUBBER BOOT ON THE MPU PATIENT CABLE CONNECTOR BLOCK WAS SEPARATING FROM THE CONNECTOR BLOCK. ALSO, CORROSION WAS FOUND ON THE MPU BATTERY TERMINALS. THE MPU BACK-UP BATTERIES ARE FOR THE MPU AUDIBLE ALARMS. DESPITE THE CORROSION, THE MPU ALARMS WERE FUNCTIONAL. THE PATIENT CABLE CONNECTOR BLOCK WAS EXAMINED AND NO INGRESS OR DAMAGE WERE FOUND. THE OVERMOLD DID NOT INTERFERE WITH POWER CABLE LEAD CONNECTIONS. THE PATIENT CABLE CONNECTORS ARE MOLDED INTO A HARD FORM BLOCK; THE BLOCK IS THEN OVER-MOLDED (WITH RUBBER). THE ISSUE WITH THE OVERMOLD WAS COSMETIC AND NOT FUNCTIONAL. THE MPU UNIT WAS OVER 4 YEARS OLD. THE REASONS FOR THE OVERMOLD SEPARATION AND TERMINAL CORROSION WAS NOT DETERMINED IN THIS ANALYSIS. THE MPU ASSEMBLY WAS MADE SEP 29, 2017. THE MPU UNIT WAS PACKAGED AND PLACED INTO STOCK ON OCT 23, 2017. THE UNIT WAS SENT TO THE CUSTOMER ON NOV 14, 2017. THE UNIT WAS ASSIGNED TO THE PATIENT ON (B)(6) 2018. SET UP AND USE OF THE MOBILE POWER UNIT (MPU) ARE DOCUMENTED IN THE HEARTMATE 3 LVAS PATIENT HANDBOOK AND THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU). MPU ALARMS AND THE PROPER ACTIONS TO BE TAKEN ARE DOCUMENTED IN THE HEARTMATE 3 PATIENT HANDBOOK ¿MPU ALARMS¿ AND THE HEARTMATE 3 LVAS IFU ¿MPU ALARMS." SPECIFIC WARNINGS AND CAUTIONS REGARDING THE MPU'S SET UP, THE POTENTIAL TRIPPING HAZARDS PRESENTED BY THE MPU PATIENT CABLE AND POWER CORD, AND THE ELECTRICAL OUTLET USED (INCLUDING LOCATION AND ACCESSIBILITY) ARE GIVEN IN BOTH THE HEARTMATE 3 LVAS PATIENT HANDBOOK AND THE HEARTMATE 3 LVAS IFU. THE HEARTMATE 3 LVAS PATIENT HANDBOOK STATES THAT THE PATIENT SHOULD CONTACT THEIR HOSPITAL SHOULD THEY BELIEVE THEIR EQUIPMENT HAS ISSUES - "IF FOR ANY REASON, ANY PORTION OF YOUR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR YOU ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT." REPLACING THE MPU BATTERIES IS DESCRIBED IN THE HEARTMATE 3 LVAS PATIENT HANDBOOK. MPU BATTERY INSPECTION AND MAINTENANCE ARE DESCRIBED IN THE MONTHLY SAFETY CHECKLIST AND SIX MONTH SAFETY CHECKLISTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT THE CASING AROUND THE BLACK AND WHITE CONNECTORS ON THE PATIENT CABLE OF THE MOBILE POWER UNIT (MPU) WERE STRETCHED OUT, ALLOWING MOVEMENT OF THE CONNECTORS. NO ALARMS ASSOCIATED WITH THE EVENT. THE MPU WILL BE RETURNED FOR EVALUATION AND IT WAS NOTED THAT A NEW POWER MODULE WAS ORDERED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354267 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male