BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5233705 · Received November 18, 2015

    Report

    Report Number
    8010762-2015-01178
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 28, 2015
    Report Date
    October 30, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS RECEIVED FOR MANUFACTURERS LABORATORY INVESTIGATION. A PERFORMANCE TEST IN THE QA LABORATORY WAS PERFORMED. DURING INVESTIGATION A TIGHTNESS TEST WAS PERFORMED. LEAKAGE AT THE TEMPERATURE SENSOR ON THE BLOOD OUTLET CONNECTOR WAS NOTICED. THE TEMPERATURE SENSOR WAS SCREWED-ON VERY TIGHT. DURING VISUAL INSPECTION A CRACK WAS NOTICED, WHICH PROCEEDS OVER THE LUER LOCK OF THE TEMPERATURE SENSOR AND THE CONNECTOR. THROUGH THE CRACK, FLUID WAS ABLE TO FLOW DOWN TO THE GAS OUTLET PORT. THAT COULD GIVE THE IMPRESSION THAT THE LEAKAGE CAME FROM GAS OUTLET PORT. BASED ON THE AVAILABLE INFORMATION AND THE INVESTIGATION RESULTS OBTAINED THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 09:33 AM (GMT-5:00) ADDED BY (B)(6): (B)(4). MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT BACK FOR INVESTIGATION BUT HAS NOT RECEIVED IT UNTIL YET. INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K132829.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: LEAKAGE FROM GAS OUTLET PORT OCCURRED. IT WAS HELD TO EXCHANGE THE MEMBRANE AND THERE WAS NO INJURY TO THE PATIENT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764231 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HLM TUBING SET W/SOFTLINE COATING 92138674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention