BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6129726 · Received November 28, 2016

    Report

    Report Number
    8010762-2016-00688
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 2, 2016
    Report Date
    February 16, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K123510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY(B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A PATIENT WAS TRANSFERRED TO THE SCANNER. TO GO TO THE SCANNER, NO PROBLEM WAS NOTICED. WHEN RETURNING, NO PROBLEM WAS NOTICED UNTIL ARRIVING IN THE ROOM. THEN THE DEVICE ALARMED AND DISPLAYED THE MESSAGE[BAT SOMETHING] AND THEN STOPPED. THE PERFUSIONIST PLUGGED THE ROTAFLOW IN AND THE DEVICE RESTARTED NORMALLY. INVESTIGATION REPORT (B)(4): AFTER PERFORMING A RUN TIME TEST, THE BATTERY HOLDS BARELY FOR 30 MINUTES. REPLACEMENT OF THE BATTERY AND FUNCTIONING TEST ARE OK. INVESTIGATION REPORT OF THE LCE (B)(4): WHEN THE BATTERY WAS DELIVERED, THE FUSE WAS BROKEN IN THE CARTON. THE FUSE (TYPT10A / 250V) WAS REPLACED AND THE AKKUPACK INSERTED INTO A ROTAFLOW CONSOLE. THE AKKUPACK WAS LOADED IN THE ACTIVATED RFC AND OVER THE SERVICE INTERFACE OF THE RFC. AFTER 7 HOURS,THE CHARGING PROCESS WAS COMPLETED BY THE CHARGE CIRCUIT OF THE RFC BATTERY VOLTAGE OF27.8 V AND A BATTERY TEMPERATURE OF 42°C. ABOUT NIGHT, THE OPEN CIRCUIT VOLTAGE OF THE RECHARGEABLE BATTERY IN THE SWITCHED-OFF RFC DROPPED TO24.8V. THIS INDICATES THAT ONE OR MORE CELLS HAVE BEEN UNEVENLY CHARGED. DURING THE NEXT DAY'S DISCHARGE AT 5000 RPM AND ABOUT 9LPM, A RUN TIME OF 1 HOUR OF THE ALARM [LOW_BAT] AND 5 MINUTES LATER THE RFC SWITCHED OFF.THUS THE FAILURE COULD BE CONFIRMED. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIANTIONS WILL BE COMPLETED AT THIS TIME

    Description of Event or Problem · 1

    DURING THE TRANSFER OF A PATIENT, THE ROTAFLOW CONSOLE STOPPED. THE MEDICAL STAFF USED ANOTHER ROTAFLOW CONSOLE. NO CLINICAL CONSEQUENCE WAS REPORTED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779821 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG MCP00702755

    Patients

    Seq Age Sex Outcome Treatment
    1