BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX D

    MDR report key: 1881248 · Received October 6, 2010

    Report

    Report Number
    8010762-2010-14610
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 2, 2010
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG, (B)(4). WE CONFIRMED THAT THERE ARE CRACKS AT THE VENOUS AND THE ARTERIAL SIDES OF THE HOUSING. ACCORDING TO THE CUSTOMER'S INFO A ROLLER PUMP WAS USED AND THE OXYGENATOR WORKED FINE UP TO SIX OR SEVEN DAYS, HOWEVER, OUR OXYGENATORS HMOD 2030 AND BBQ-HMOD HAVE AN INDICATIONS FOR USE FOR ONLY UP TO SIX HOURS. WE HAVE TRIED TO SIMULATE THIS FAILURE IN THE LABORATORY WITH LONG TERM TESTS USING THE ROLLER PUMP. THE TESTS OF 4 OXYGENATORS RAN WITH ROLLER PUMPS DURING 20 DAYS AT A TEMPERATURE OF 37 DEGREE C, A PRESSURE OF 500 MMHG AND A WATER FLOW OF 4 1/MIN. NO CRACKS COULD BE OBSERVED AFTER AND DURING RUNNING THE TESTS. THEREFORE, THE ROOT CAUSE COULD NOT BE CONFIRMED. HOWEVER, WE ARE CONFIDENT THAT THE MOST PROBABLE ROOT CAUSE FOR THESE CRACKS IS THE PROLONGED USE IN COMBINATION WITH USING A ROLLER PUMP, WHERE THE OXYGENATOR MAY BECOME STRESSED DUE TO PULSATION OVER TIME. OUR BASIS FOR THIS IS THAT MAQUET CARDIOPULMONARY AG HAS CE CERTIFIED SYSTEMS FOR LONG-TERM USE OUTSIDE THE U.S. WHICH ONLY INCLUDE CENTRIFUGAL PUMPS RATHER THAN ROLLER PUMPS AND PROBLEMS WITH CRACKS ARE NOT KNOWN WITH THESE SPECIAL TUBING SETS. WE BELIEVE THAT THIS TYPE OF FAILURE CAN BE AVOIDED IN THE FUTURE BY THE CUSTOMER'S ADHERENCE TO THE PRODUCT'S INSTRUCTIONS FOR USE WHICH SPECIFIES THAT THE UTILIZATION PERIOD IS RESTRICTED TO SIX HOURS. (B)(4).

    Description of Event or Problem · 1

    OXYGENATOR DEVELOPED A CRACK ON THE HOUSING AFTER SIX OR SEVEN DAYS OF USE. THE EQUIPMENT WAS CHANGED OUT. THERE WERE NO LEAKS NOTICED AND THERE WAS NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D OXYGENATOR SYSTEM DTZ MAQUET CARDIOPULMONARY AG HMOD 2030 70041436

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other