BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5791937 · Received July 13, 2016

    Report

    Report Number
    8010762-2016-00445
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 23, 2016
    Report Date
    March 21, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS REQUESTED TO RETURN FOR MANUFACTURERS LABORATORY INVESTIGATION, BUT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS TESTED WITH BOVINE BLOOD IN THE LABORATORY OF THE MANUFACTURER FOR ITS O2, CO2 TRANSFER RATE AS WELL AS FOR ITS PRESSURE DROP BEHAVIOR AT MAXIMUM FLOW. THE PRODUCT WAS OPERATING ACCORDING TO THE ACCEPTANCE CRITERIA'S AND THEREFORE PASSED THE TEST SUCCESSFULLY. BASED ON THESE RESULTS AND THE INFORMATION AVAILABLE AT THIS TIME NO DEVICE RELATED MALFUNCTION COULD BE CONFIRMED. THE MOST PROBABLE CAUSE OF THE INCIDENT IS UNKNOWN. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND NO SYSTEMIC ISSUE COULD BE DETERMINED NO CORRECTIVE ACTION IS NEEDED AT THIS TIME. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: PT WAS ACCESSED FOR VA ECLS (VENO ARTERIAL EXTRA CORPORAL LIFE SUPPORT) VIA RIGHT FEMORAL ARTERY AND RIGHT FEMORAL VEIN IN THE CATHLAB. THE CARDIOHELP HLS CONSOLE AND 7.0 DISPOSABLE KIT WAS PRE-PRIMED AND HANDED UPWARD TO THE SURGICAL FIELD FOR INITIATION OF VA ECLS SUPPORT. AFTER APPROPRIATE HEPARIN BOLUS, CONNECTION OF BOTH CANNULA, CLAMPS OPENED, AND INSTRUCTIONS TO INITIATE ECLS SUPPORT, THE PERFUSIONIST REPORTED HE COULD NOT ESTABLISH FORWARD FLOW THRU THE HLS DISPOSABLE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442880 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1