BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5162852 · Received October 20, 2015

    Report

    Report Number
    8010762-2015-01113
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCTOBER 16, 2015 04:48 PM (GMT-4:00) ADDED BY (B)(6): (B)(4). 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): K082117.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015 09:16 AM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): THE PRODUCT HAS BEEN RECEIVED IN THE LABORATORY OF THE MANUFACTURER AND A VISUAL INSPECTION WAS PERFORMED. THE COMPLAINED BLACK MARKED GLUE CONNECTION BETWEEN THE BLOOD INLET CONNECTOR AND OXY DID NOT SHOW ANY LEAKAGE. DURING A TIGHTNESS TEST A CRACK IN THE LUER LOCK ON THE BLOOD INLET CONNECTOR COULD BE DETERMINED AS CAUSE FOR THE LEAKAGE. THEREFORE THE REPORTED FAILURE COULD BE CONFIRMED. AT THE DAMAGED LUER LOCK A FOREIGN SCREW CAP WAS MOUNTED. BUT THE FOREIGN SCREW CAP COULD NOT BE DETERMINED AS A CAUSE OF THE MALFUNCTION. BECAUSE THE LUER AT THE CONNECTOR IS STANDARDIZED ACCORDING TO (B)(4). THE FOREIGN SCREW CAP EXISTS OF A NOTABLE MORE SOFTEN MATERIAL THAN THE MATERIAL OF THE CONNECTOR. THEREFORE THE FOREIGN SCREW CAP SUITED WITH THE LUER LOCK. FURTHERMORE A DEVICE HISTORY RECORD OF THE COMPLAINED LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. 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

    DESCRIPTION FROM THE CUSTOMER REPORT: LEAKING FROM ARTERIAL OUTLET. NOTICED ON PRIMING SO CHANGED OUT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693217 HLM TUBING SET W/SOFTLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HQV 52402 92161188

    Patients

    Seq Age Sex Outcome Treatment
    1