BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET

    MDR report key: 5204744 · Received November 5, 2015

    Report

    Report Number
    8010762-2015-01145
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) WILL NOT BE ABLE TO INVESTIGATE THE PRODUCT BECAUSE THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). BASED ON THE RECEIVED INFORMATION THE DISPOSABLE WORKED AS PER SPECIFICATION DESCRIBED. THE PRODUCT WAS REPLACED DURING TREATMENT AS A SAFETY MEASURE. NO FAILURE DESCRIPTION WAS RECEIVED FOR THE DISPOSABLE, THEREFORE NO FAILURE COULD BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION #(B)(4). 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

    IT WAS REPORTED THAT THE BUBBLE DETECTOR WENT OFF AND BOTH THE HARDWARE UNIT AND DISPOSABLE WERE CHANGED OUT. THIS REPORT PERTAINS TO THE DISPOSABLE. NO REPORTED PATIENT EFFECT. (B)(4). COMPLAINT RELATED TO (B)(4) FOR THE CARDIOHELP HARDWARE DEVICE4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733658 HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HLS 7050NS USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention