BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4768425 · Received May 11, 2015

    Report

    Report Number
    8010762-2015-00443
    Event Type
    Injury
    Date Received
    May 11, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED EVENT AND OUR INVESTIGATIONS, THE REPORTED EVENT IS CAUSED BY USE THAT IS BEYOND THE USAGE DESCRIBED IN OUR LABELING AND CLEARED INTENDED USE. THE INSTRUCTIONS FOR USE (IFU) ART. # 70105.2895, COMMON DEVICE NAME: CARDIOHELP SYSTEM US-03) CLEARLY STATE THE FOLLOWING: CHAPTER 1.2: INTENDED USE: "THE CARDIOHELP SYSTEM IN CONFIGURATION WITH THE HLS/HIT SET ADVANCED IS INTENDED TO BE USED WITHIN THE HOSP ENVIRONMENT AND OUTSIDE THE HOSP ENVIRONMENT (FOR PERIODS UP TO SIX HOURS), E.G. FOR INTRA- AND INTER-HOSPITAL TRANSPORT." ADDITIONAL INFO: THE PRODUCT MENTIONED UNDER SECTION D 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

    DESCRIPTION FROM THE CUSTOMER REPORT: "CUSTOMER STATED THAT AFTER 41 DAYS OF THERAPY THEY WERE SURPRISED TO SEE BLOOD CLOTS IN HLS MODULE. NO PT DEATH OR HARM." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308293 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other