BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I HMO 70000+VHK70000

    MDR report key: 4901414 · Received July 7, 2015

    Report

    Report Number
    8010762-2015-00793
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION AND AN INTERNAL PROCESS (B)(4) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. DUE TO THIS, NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS DATA IS BEING HANDLED THROUGH A MAQUET CARDIOPULMONARY TRACKING AND TRENDING PROCESS. ABBREVIATION NC: NONCONFORMANCE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED, IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I, WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIQUID WAS OOZING OUT OF THE HYDROPHOBIC FILTER. PRODUCT WAS NOT REPLACED AS PATIENT WAS ON BY PASS WHEN THE LEAK WAS NOTICED. THERE WAS NO DELAY IN TREATMENT. NO KNOWN CONSEQUENCE TO THE PATIENT CAN BE RELATED TO THE LEAK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440794 QUADROX-I HMO 70000+VHK70000 DTZ MAQUET CARDIOPULMONARY AG VKMO 78000 92145942

    Patients

    Seq Age Sex Outcome Treatment
    1