BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR

    MDR report key: 4268478 · Received November 21, 2014

    Report

    Report Number
    8010762-2014-01297
    Event Type
    Malfunction
    Date Received
    November 21, 2014
    Date of Event
    July 30, 2011
    Report Date
    November 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K100278
    Removal / Correction Number
    Z-0689-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. PER THE RETROSPECTIVE SUMMARY REPORT APPROVAL NUMBER- (B)(4) DATED ON JULY 24, 2014, A SUMMARY IS REQUIRED OF THE DTZ CREATED. A TOTAL OF 287 REPORTABLE EVENTS ARE CAPTURED IN THE SPREADSHEET. A ROOT CAUSE ANALYSIS WAS PERFORMED TO DETERMINE THE CAUSE OF LATE MDR REPORTING DURING THIS PERIOD. THE RESULT OF THE ROOT CAUSE ANALYSIS IDENTIFIED THAT THE MDR PROCEDURES WERE NOT SUFFICIENT TO ASSURE THAT MDR REPORTING IS CONSISTENT OR COMPLETED IN A TIMELY MANNER. THE PROCEDURES HAVE BEEN REVISED AND IMPLEMENTED AND MDR FILING METRICS ARE INCLUDED IN THE MONTHLY QUALITY DATA REVIEW TO ENSURE TIMELY FILING. REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6) HOSPITAL OF (B)(6) OBSERVED LEAKING ON QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE (LOT NUMBER 70064004) DURING PRIMING. THE OXYGENATOR WAS REPLACED THREE TIMES. REFERENCE: COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757073 QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR DTZ DTZ MAQUET CARDIOPULMONARY AG 70105.330 70064004

    Patients

    Seq Age Sex Outcome Treatment
    1