BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VKMO 70000 #QUADROX-I HMO 70000+VHK71

    MDR report key: 4550627 · Received February 23, 2015

    Report

    Report Number
    8010762-2015-00110
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    December 13, 2014
    Report Date
    December 15, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. ADDITIONAL INFO: 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 INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMING, CONTINUOUS AIR WAS IN THE VENOUS LINE. THE LEAKAGE WAS NOTED IN THE RESERVOIR VENOUS INLET PORT IN THE TEMPERATURE PROBE. LEAKAGE REPAIR, CHECKED AGAIN, OK. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126217 VKMO 70000 #QUADROX-I HMO 70000+VHK71 RESERVOIR DTN MAQUET CARDIOPULMONARY AG 70106.4523 92138699

    Patients

    Seq Age Sex Outcome Treatment
    1