BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BO-HQV 70600#ADULT PACK

    MDR report key: 4536042 · Received February 19, 2015

    Report

    Report Number
    8010762-2015-00097
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 21, 2014
    Report Date
    January 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A FOLLOW UP MEDWATCH WILL BE SENT WHEN ADD'L INFO IS RECEIVED. ADD'L INFO: THE PRODUCT MENTIONED, IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF TH RESERVOIR WHICH IS REGISTERED UNDER 510 (K): K102919.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TEMPERATURE PROBE AT THE VENOUS INLET WAS NOT TIGHT. AIR WAS CONSTANTLY BEING SUCKED INTO THE VENOUS RESERVOIR. THE TEMPERATURE PROBE WAS REMOVED AND REPLACED WITH A PLUG FROM THE RESERVOIR. THIS DID NOT SOLVE THE PROBLEM. THINK IT MAY BE FEMALE LUER LOCK IN WHICH THE PROBE IS INSERTED AND NOT THE TEMPERATURE PROBE. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119687 BO-HQV 70600#ADULT PACK RESERVOIR DTN MAQUET CARDIOPULMONARY AG BO-HQV 70600 92119899

    Patients

    Seq Age Sex Outcome Treatment
    1