BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID PAD.O.FILT

    MDR report key: 4871775 · Received June 25, 2015

    Report

    Report Number
    8010762-2015-00738
    Event Type
    Death
    Date Received
    June 25, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A CLINICAL EVALUATION OF THE CURRENT AVAILABLE INFORMATION WAS PERFORMED WITH THE FOLLOWING CONCLUSION: MULTIPLE FACTORS, INCLUDING NON-DEVICE RELATED INFLUENCE COULD HAVE LEAD TO THE DESCRIBED PRESSURE RISE. BASED ON THE LEVEL OF INFORMATION THAT COULD BE OBTAINED AND THAT THE SAMPLE IS NOT AVAILABLE A ROOT-CAUSE COULD NOT BE DEFINED. PROLONGED USE-MORE THAN THE 6 HOURS NOTED IN THE IFU MAY HAVE BEEN A CONTRIBUTING FACTOR. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). RELATED COMPLAINTS: (B)(4) (8010762-2015-00737 AND 3008355164-2015-00129). (B)(4) (8010762-2015-00735 AND 3008355164-2015-00128). (B)(4) (8010762-2015-00735 AND 3008355164-2015-00127.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411825 QUADROX-ID PAD.O.FILT DTZ DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1