BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART-LUNG MACHINE HL20

    MDR report key: 6112684 · Received November 18, 2016

    Report

    Report Number
    8010762-2016-00684
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SAFETY ENGINEER WAS SENT FOR INVESTIGATION AND DONE FOLLOWING: MEASURED RESISTANCE FROM MOTOR CARBON BRUSHES WITH RESPECT TO MOTOR CASING, RESISTANCE IS APPROX. 325K OHMS. REPLACED DRIVE MOTOR AND DRIVE BELTS; INSERTED NEW EEPROM ONTO PUMP CONTROL PCB; ADJUSTED BELT TENSION; CHECK AND ADJUSTED PUMP MOTOR SPEED - FORWARD AND REVERSE; CHECK PUMP ALARMS; PERFORM FUNCTIONAL TESTS; VERIFY PUMP MEETS FACTORY SPEC'S. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. 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 INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "RPM_DIFF ERROR OCCURED". NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764402 HEART-LUNG MACHINE HL20 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1