BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID

    MDR report key: 2891370 · Received December 21, 2012

    Report

    Report Number
    8010762-2012-00054
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 24, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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. THE DEVICE WAS MANUFACTURED IN 02/2011. THE OXYGENATOR IS BEING HELD BY THE FACILITY'S RISK MANAGEMENT DEPARTMENT AND IS CURRENTLY UNAVAILABLE FOR EVALUATION. IF THE DEVICE BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE FACILITY REPORTED THAT THEY WERE AWARE OF THE FIELD SAFETY NOTICE DATE 06/2012 ASSOCIATED WITH THIS ISSUE AND THAT THEY HAD VERIFIED THE INTEGRITY PRIOR TO USE. THE FACILITY REPORTER IS UNSURE IF THE CONNECTOR WAS BUMPED OR SUBJECTED TO ANY OTHER MECHANICAL STRESS PRIOR TO THE CONNECTOR DISCONNECTING FROM THE DEVICE. ITEMS MARKED NI ARE UNK TO US AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF AN OXYGENATOR A NURSE INITIALLY NOTICED A FEW DROPS OF BLOOD. SOME TIME PASSED AND MORE BLOOD WAS OBSERVED ON THE FLOOR. UPON INSPECTION OF THE OXYGENATOR, A STEADY FLOW OF BLOOD FROM THE ARTERIAL OUTLET WAS DETECTED. THE FACILITY REPORTED THAT THE LEAK WAS NOT ON THE PORT, BUT THE HOUSING PERPENDICULAR TO THE FLOW AND POSSIBLY ALONG A SEAM. WHILE REPLACING THE OXYGENATOR THE ARTERIAL OUTLET DISCONNECTED. THE OXYGENATOR WAS SUCCESSFULLY REPLACED. NO PT INJURY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-ID OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HMOD70000-USA 70062354

    Patients

    Seq Age Sex Outcome Treatment
    1 NI