BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4768713 · Received May 11, 2015

    Report

    Report Number
    8010762-2015-00444
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING PROCESS OF THE RAW MATERIAL FIBERS USED IN THE OXYGENATOR. IF, DURING THE SURFACE PRE-TREATMENT, A SYSTEM MALFUNCTION RESULTS IN A SYSTEM STOP, THE ENTIRE LENGTH OF THE FIBER IS NOT PROPERLY TREATED TO MODIFY THE SURFACE TENSION. IF THERE UNTREATED FIBERS ARE PRESENT IN THE EPOXY AREA OF THE OXYGENATOR, IT IS NOT PROPERLY FIXED IN THE EPOXY. WHEN THIS OCCURS THE FIBERS AREA ABLE TO "SHRINK OUT" OF THE EPOXY AND RESULT IN THE REPORTED LEAKAGE. THE RAW MATERIAL MANUFACTURER HAS INITIATED STEPS TO REPEAT THE SURFACE -PRE-TREATMENT TO ENSURE THAT THE PROPER SURFACE TENSION IS PRESENT ON THE ENTIRE LENGTH OF THE FIBERS. ADDITIONAL INFO: 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: "A LEAKAGE LOCATED IN THE GAS OUTLET APPEARED JUST AFTER THE PRIMING. THE SET WAS NOT CONNECTED TO THE PT. NO CLINICAL CONSEQUENCE WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308418 HLM TUBING SET W/BIOLINE COATING DTZ (OR DWE) DTZ MAQUET CARDIOPULMONARY AG BO-PLS 2051 70099593

    Patients

    Seq Age Sex Outcome Treatment
    1