BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VKMO 11000

    MDR report key: 4552961 · Received February 24, 2015

    Report

    Report Number
    8010762-2015-00116
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    December 31, 2014
    Report Date
    January 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE DHR DOES NOT CONTAIN ANY ABNORMALITIES. THE PROBABLE ROUTE CAUSE IS PATIENT RELATED CLOTTING. THE MALFUNCTION IS NOT REPRODUCIBLE. THERE ARE NO ADDITIONAL INFORMATION AVAILABLE FOR THIS INCIDENT. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. NO FURTHER INVESTIGATION WILL BE CONDUCTED AT THIS TIME. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510(K): K102919. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD WAS FOUND CLOTTING IN THE BLOOD RESERVOIR. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128156 VKMO 11000 RESERVOIR DTZ MAQUET CARDIOPULMONARY AG VKM0 11000 92137820

    Patients

    Seq Age Sex Outcome Treatment
    1