BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4780845 · Received May 15, 2015

    Report

    Report Number
    8010762-2015-00459
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND UNDER OPTICAL MICROSCOPE DELAMINATION OF THE SOME GAS FIBERS WERE OBSERVED. HENCE, THE PRIMING SOLUTION OR BLOOD WAS ABLE TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND THE GRAVITY GUIDED IT TO THE GAS EXITING PATH ALONG THE HOUSING. THE MFR INITIATED A CUSTOMER NOTIFICATION CONCERNING THE PROBLEM, THE POTENTIAL RISK AND THE RECOMMENDED HANDLING IN THE EVENT THIS FAILURE OCCURS (FSCA # 2014-12-11). THE INVESTIGATION UNDER CAPA PROCESS (CAPA (B)(4)) HAS IDENTIFIED THAT THE ROOT CAUSE IS DUE TO THE MFG 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 THESE UNTREATED FIBERS ARE PRESENT IN THE EPOXY AREA OF OXYGENATOR, IT IS NOT PROPERLY FIXED IN THE EPOXY. WHEN THIS OCCURS, THE FIBERS ARE ABLE TO "SHRINK OUT" OF THE EPOXY AND RESULT IN THE REPORTED LEAKAGE. THE RAW MATERIAL MFR 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. ADD'L 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: "LEAKAGE OCCURRED DURING PRIMING AND CIRCUIT CHECK (BEFORE PUTTING ON PT). LEAKAGE AT THE GAS EXHAUST PORT OF THE OXYGENATOR". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317708 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-HLS 7050 70100110

    Patients

    Seq Age Sex Outcome Treatment
    1