BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

    MDR report key: 4567658 · Received February 25, 2015

    Report

    Report Number
    8010762-2015-00104
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K090534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE REPORTED, IS A COMPONENT OF THE VENOUS HARDSHELL CARDIOTOMY RESERVOIR CLEARED UNDER 510(K) K090534.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 3/8 CONNECTION MOUNTED ON THE INLET OF THE DEVICE WAS BROKEN, WHICH CAUSED RINGER SOLUTION TO LEAK DURING PRIMING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134691 VKMO 78000 3 QUADROX-I HMO 70000+VHK7000 DTZ MAQUET CARDIOPULMONARY AG VKMO 78000

    Patients

    Seq Age Sex Outcome Treatment
    1