BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9450675 · Received December 11, 2019

    Report

    Report Number
    2916596-2019-05535
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    August 20, 2019
    Report Date
    December 30, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILE. THE SUBMITTED LOG FILE SHOWED THAT IT CONTAINED APPROXIMATELY 30 DAYS AND 13 HOURS OF DATA (B)(6) 2019, PER THE TIME STAMP). ON (B)(6) 2019, THE LOG FILE RECORDED MULTIPLE LOW SPEED OPERATION AND PUMP STOP EVENTS AS WELL AS THE DRIVELINE BEING DISCONNECTED TWICE DURING THE ABNORMAL PUMP OPERATION EVENTS; THESE EVENTS WERE FURTHER EVALUATED UNDER THE PUMP INVESTIGATION REPORTED IN MFR# 2916596-2019-04248. ON (B)(6) 2019 AT 19:16:11, THE RSOC VOLTAGE LEVELS OF BOTH POWER CABLES DROPPED FROM THE EXPECTED ~12.9V DOWN TO ~3.3V ACTIVATING POWER CABLE DISCONNECT, LOW BATTERY HAZARD, AND NO EXTERNAL POWER ALARMS. THE ASSOCIATED VOLTAGE LEVELS INDICATED THAT THE ALARMS OCCURRED WHEN THE SYSTEM CONTROLLER WAS POWERED BY A MOBILE POWER UNIT (MPU) AND INDICATED AN INTERMITTENT LOSS OF POWER; THE ALARMS CLEARED WHEN THE AC POWER WAS RESTORED. PUMP SUPPORT WAS NOT AFFECTED DURING THIS EVENT AS THE SYSTEM WAS SUPPORTED BY THE BACKUP BATTERY AS INTENDED. DESPITE THESE EVENTS, NO OTHER ATYPICAL EVENTS OR ALARMS WERE CAPTURED IN THE LOG FILE. VISUAL INSPECTION OF THE MOBILE POWER UNIT ASSOCIATED WITH THE COMPLAINT WAS NOT CONDUCTED AS THE DEVICE WAS NOT RETURNED TO ABBOTT FOR EVALUATION NOR THE SERIAL NUMBER WAS REPORTED. ADDITIONAL PROVIDED INFORMATION INDICATED THAT THE MPU DOES NOT HAVE A V-LOCK CONNECTOR ON THE A/C POWER CORD. THE VAD COORDINATOR ALSO STATED THAT IT WAS UNKNOWN IF THE POWER CORD CAME LOOSE AT THE WALL/OUTLET OR THE BACK OF THE UNIT, AND THERE NO ENVIRONMENTAL CIRCUMSTANCES THAT WOULD HAVE AFFECTED A/C POWER AT THE TIME OF THE EVENT (I.E LOSS OF POWER TO THE HOUSE). MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE MPU ASSOCIATED WITH THE FILE; HOWEVER, NO FURTHER DETAILS WERE PROVIDED. BASED ON THE LOG FILE ANALYSIS, A ROOT CAUSE FOR THE NO EXTERNAL POWER ALARM RECORDED IN THE LOG FILE APPEARED TO BE RELATED TO A LOSS OF THE AC POWER WHILE CONNECTED TO THE MPU. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PMA/510# P160054.

    Description of Event or Problem · 1

    UPON EVALUATION OF THE SUBMITTED LOG FILE, A NO EXTERNAL POWER EVENT ALARM WAS REVEALED ON (B)(6) 2019 AT 7:16:11 PM DUE TO LOSS OF AC POWER WHILE CONNECTED TO THE MPU. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248888 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR