BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 7692198 · Received July 16, 2018

    Report

    Report Number
    2916596-2018-02850
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 3, 2018
    Report Date
    February 23, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOBILE POWER UNIT REMAINS IN CLINICAL USE AND THE PATIENT CONTINUES ON VAD SUPPORT. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. EVALUATION OF THE SUBMITTED LOG FILE CONFIRMED NO EXTERNAL POWER ALARMS WHILE THE PATIENT'S LVAS SYSTEM WAS POWERED BY THE MOBILE POWER UNIT; HOWEVER, A SPECIFIC CAUSE FOR THIS FINDING AND A DIRECT CORRELATION TO THE MOBILE POWER UNIT COULD NOT BE CONCLUSIVELY ESTABLISHED. THE HEARTMATE II LVAS PATIENT HANDBOOK ADDRESSES ALL ALARM CONDITIONS INCLUDING NO EXTERNAL POWER ALARMS AND CAUTIONS THE USERS 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. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE FOR THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION G4: THE DEVICES PMA NUMBER WAS MISSING IN PREVIOUS REPORTS. THE PMA NUMBER IS P060040.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. GE OF DEVICE: 1 YEAR, 7 MONTHS, 19 DAYS. THE PATIENT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT LVAD SYSTEM PRODUCED 'NO EXTERNAL POWER' AND 'LOW VOLTAGE' ALARMS ON (B)(6) 2018. THE SYSTEM CONTROLLER'S INTERNAL BATTERY SUPPLIED POWER TO THE PUMP AS DESIGNED DURING THE EVENT. THE PATIENT REMAINED ASYMPTOMATIC. IT WAS REPORTED THAT THE POWER CORD OF MOBILE POWER UNIT (MPU) CAME LOOSE FROM THE BACK OF MPU WHICH MAY BE ASSOCIATED WITH THE ALARMS. THE PATIENT WAS SUPPLIED WITH A VLOCK POWER CABLE AND THE ISSUES RESOLVED. NO EQUIPMENT WAS EXCHANGED. IT WAS REPORTED THAT PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533490 HEARTMATE MOBILE POWER UNIT, NA MOBILE POWER UNIT DSQ THORATEC CORPORATION 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR