BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 3560882 · Received November 6, 2013

    Report

    Report Number
    8010762-2013-00068
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT IS RELATED TO MEDWATCH REPORT NUMBERS: 8010762-2013-00066, 8010762-2013-00067, 8010762-2013-00069, 8010762-2013-0070, 8010762-2013-00071, 8010762-2013-00072, AND 8010762-2013-00073.

    Description of Event or Problem · 1

    WHEN THE CUSTOMER INITIALLY TURNED ON THE PUMP, ARTERIAL MODE WAS SET. THIS MODE INCLUDES INTERVENTIONS SUCH AS PUMP STOP DUE TO LOW BLOOD LEVEL IN RESERVOIR. WHEN SWITCHING THE PUMP OFF AND ON AGAIN, FREE MODE WAS SELECTED INSTEAD OF ARTERIAL MODE. IN FREE MODE, NO INTERVENTIONS ARE ACTIVATED. THE USER WILL SEE THIS CHANGE IN THE PUMP DISPLAY (FREE MODE WILL BE DISPLAYED) AND ON ANOTHER DISPLAY. THIS ERROR WILL ALSO BE DETECTED DURING STARTUP OF THE HEART-LUNG-MACHINE WHILE CHECKING THE SYSTEM. WHEN DETECTING FREE MODE, THE USER STILL HAS THE OPPORTUNITY TO SWITCH TO ARTERIAL MODE BUT IT WILL LEAD TO A DELAY OF APPROXIMATELY 10 TO 20 SECONDS BEFORE IT CAN BE USED ON A PATIENT. THIS DELAY MAY HAVE ADVERSE CONSEQUENCES FOR THE PATIENT. ACCORDING TO THE USER, THIS ERROR OCCURRED ON 8 HEAR-LUNG-MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573654 MAQUET CARDIOPULMONARY AG HL 20 4-PUMPS CONSOLE BASE DTQ MAQUET CARDIOPULMONARY AG 70102.8580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI