BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 8123299 · Received December 2, 2018

    Report

    Report Number
    2916596-2018-05288
    Event Type
    Injury
    Date Received
    December 2, 2018
    Date of Event
    November 15, 2018
    Report Date
    February 28, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE REPORT OF LOW VOLTAGE ALARMS WHILE CONNECTED TO BATTERIES AND A NO EXTERNAL POWER ALARM WHILE CONNECTED TO A MPU BY TECHNICAL SERVICE¿S DURING THEIR REVIEW OF THE SUBMITTED LOG FILES WAS CONFIRMED. THE SUBMITTED EVENT LOG WAS FROM SYSTEM CONTROLLER HSC-061899 AND CONTAINED APPROXIMATELY 7 DAYS OF DATA FROM ON (B)(6) 2018, PER THE TIME STAMP. ON (B)(6) 2018 AT 19:27 A LOW POWER ADVISORY ALARM WAS CAPTURED THAT WAS THE RESULT THE BATTERIES RUNNING DOWN TO THE ADVISORY THRESHOLD. A LOW POWER HAZARD WAS ALSO CAPTURED THAT WAS DUE TO THE CONTROLLER BEING SUPPORTED BY ONE LOW BATTERY WHILE THE PATIENT CONNECTED TO A CHARGED BATTERY. THE CONTROLLER WAS CONNECTED TO CHARGED BATTERIES AT 19:28 AND THE ALARMS RESOLVED. LOW POWER HAZARD AND NO EXTERNAL POWER ALARMS WERE CAPTURED ON (B)(6) 2018 AT 07:58 OVER AN 11 SECOND TIMESPAN. THE EVENT WAS CONSISTENT WITH A LOSS OF AC POWER TO A MPU. THE CONTROLLER'S BACKUP BATTERY POWERED THE PUMP AS INTENDED DURING THE LOSS OF POWER. POWER WAS RESTORED TO THE MPU AND THE ALARMS RESOLVED. THE REMAINING EVENTS WERE UNREMARKABLE AND THE PUMP SPEED WAS RECORDED AT THE SET SPEED THROUGHOUT THE LOG FILE. THE MPU WAS NOT RETURNED FOR ANALYSIS AND THE SERIAL NUMBER WAS NOT REPORTED. SEVERAL GOOD FAITH EFFORTS WERE MADE TO THE ACCOUNT ASKING FOR ADDITIONAL INFORMATION, INCLUDING WHAT THE SERIAL NUMBER OF THE MPU WAS AND WHETHER THE NO EXTERNAL POWER ALARM WAS CAUSED BY THE POWER CORD COMING LOOSE FROM THE BACK OF THE MPU; HOWEVER, AT THIS TIME NO RESPONSE HAS BEEN RECEIVED. IT IS UNKNOWN WHETHER THE MPU HAD A V-LOCK AC POWER CORD INSTALLED. IT WAS RECOMMENCED BY TECHNICAL SERVICES THAT IF THE PATIENT DOES NOT HAVE A LOCKING MPU AC POWER CORD TO CONTACT THE CLINICAL SPECIALIST TO ASSIST IN ORDERING ONE. THE SPECIFIC CAUSE OF THE LOSS OF AC POWER WAS UNABLE TO BE CONCLUSIVELY DETERMINED DURING THIS INVESTIGATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE SERIAL NUMBER OF THE DEVICE WAS REQUESTED BUT WAS NOT PROVIDED, THEREFORE THE MANUFACTURE DATE AND AGE OF DEVICE ARE UNKNOWN. 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT ANALYSIS OF A LOG FILE SUBMITTED TO THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE REVEALED A NO EXTERNAL POWER ALARM WHILE THE VAD WAS CONNECTED TO A MOBILE POWER UNIT (MPU). THIS EVENT MAY HAVE BEEN CAUSED BY THE MPU'S POWER CORD COMING LOOSE FROM THE BACK OF THE MPU OR THE WALL OUTLET. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT DUE TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962995 HEARTMATE MOBILE POWER UNIT, NA MOBILE POWER UNIT DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other