BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BO-HQV #70600ADULT PACK

    MDR report key: 4580948 · Received March 4, 2015

    Report

    Report Number
    8010762-2015-00240
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, 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 TOP OF THE RESERVOIR. THIS DID NOT SOLVE THE PROBLEM. THE FEMALE LUER LOCK IN WHICH THE PROBE IS INSERTED IS BELIEVED TO BE THE PROBLEM. NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151487 BO-HQV #70600ADULT PACK RESERVOIR DTN MAQUET CARDIOPULMONARY AG BO-HQV 70600 92119899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other