BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-ID

    MDR report key: 4635741 · Received March 23, 2015

    Report

    Report Number
    8010762-2015-00298
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    March 9, 2015
    Report Date
    March 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY HAS NOT YET RECEIVED THE PRODUCT FOR INVESTIGATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510(K): K101153.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "BLACK SUBSTANCE NOTICED DURING PRIMING, WHEN THERE WAS TROUBLE PRIMING. USED ANOTHER DISPOSABLE PLACED TO THE SIDE FOR INSPECTION." "WHILE ATTEMPTING TO WET PRIME A QUADROX ID OXYGENATOR FROM LOT# 70100705 WE ENCOUNTERED AN AIR LEVEL ON THE VENOUS SIDE THAT WE WERE NOT ABLE TO REPLACE WITH CRYSTALLOID. ON FURTHER EXAM OF THE VENOUS SIDE OF THE OXYGENATOR WE NOTED SOME BLACK DEBRIS PRESENT WITHIN THE OXYGENATOR. WE THEN ABANDONED ANY ATTEMPT TO PRIME THE OXYGENATOR." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194575 QUADROX-ID DTZ DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70100705

    Patients

    Seq Age Sex Outcome Treatment
    1