BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 5039351 · Received August 28, 2015

    Report

    Report Number
    8010762-2015-01025
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. MAQUET CARDIOPULMONARY (B)(4) IS AWARE ABOUT A SIMILAR COMPLAINT. THEREBY THE PRODUCT WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER. IT WAS DETERMINED THAT THE BLUE FILTER CAP COULD BE REMOVED EASILY BY HAND. FURTHERMORE A DEVICE HISTORY RECORD WAS PERFORMED FOR THE COMPLAINED PRODUCT OF COMPLAINT # (B)(4) BY MAQUET (B)(4). THEREBY NO ABNORMALITY WAS FOUND. MOREOVER NO SCRAP RECORD FOR THE RELATED MATERIAL WAS FOUND. A PROBABLE CAUSE WAS DETERMINED AS A MATERIAL FAILURE ACCORDING TO THE RECEIVED SUPPLIER COMPLAINT STATEMENT. BASED ON THE INVESTIGATION RESULTS OF A SIMILAR COMPLAINT AND THE INFORMATION AVAILABLE AT THIS TIME THE REPORTED FAILURE COULD BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THEREFORE THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE CLOSING CAP AIR INTAKE OF THE CARDIOTOMY FILLING LINE DOES NOT HOLD AND THERE ARE BLOOD LEAKAGES WHEN FILLING WITH RED BLOOD CELLS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572799 HLM TUBING SET W/SOFTLINE COATING CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG HQV 7001 92163315

    Patients

    Seq Age Sex Outcome Treatment
    1