BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 5412944 · Received February 5, 2016

    Report

    Report Number
    8010762-2016-00064
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 21, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS REQUESTED FOR MANUFACTURER LABORATORY INVESTIGATION AND WAS NOT YET BEEN RECEIVED. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN 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-ID WHICH IS REGISTERED UNDER 510(K): K101153.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER. A TIGHTNESS TEST WAS PERFORMED. LEAKAGE ON 3 POSITIONS ( TUBING CONNECTION ON BLOOD INLET, TUBING CONNECTION ON BLOOD OUTLET, TUBING CONNECTION OF MBU SENSOR) WAS CONFIRMED. BASED ON THIS THE FAILURE "LEAK POST FILTER WHERE CONNECTED TO TUBE" COULD BE CONFIRMED. MOST PROBABLE THE LEAKAGE WAS CAUSED BY UNTIGHT TUBING CONNECTIONS. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER DETECTED A LEAK POST FILTER, WHERE CONNECTED TO THE TUBE DURING PRIMING." (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71179 HLM TUBING SET W/BIOLINE COATING TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG H 46330

    Patients

    Seq Age Sex Outcome Treatment
    1