BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-I HMO 70000+VHK7000

    MDR report key: 4531604 · Received February 17, 2015

    Report

    Report Number
    8010762-2015-00080
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 19, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG WILL NOT BE RECEIVING THE DEVICE FOR INVESTIGATION. MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FOR THIS PRODUCT AND AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT-CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. MAQUET CARDIOPULMONARY AG WILL CONTINUE TO MONITOR INCOMING REPORTS FOR ANY TRENDS AND TO DETERMINE IF FURTHER ACTION IS NECESSARY. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION DIS A VKMO AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K) : K101153. ABBREVIATIONS: MRB: MATERIAL REVIEW BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE FROM THE AIR OUTLET OF THE DEVICE DURING USE. THE DEVICE WAS EXCHANGED IMMEDIATELY. NO REPORTED PATIENT EFFECT. NO DELAY IN THERAPY AND NO RED BLOOD CELL UNITS WERE USED. ADDITIONAL INFO RECEIVED ON (B)(6) 2015: THE LEAKAGE WAS AT DE-AERATION MEMBRANE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112263 QUADROX-I HMO 70000+VHK7000 VKMO 78000 #QUADROX-I HMO 70000+VHK7000 DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92143456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention