BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 6198357 · Received December 22, 2016

    Report

    Report Number
    8010762-2016-00733
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 22, 2016
    Report Date
    July 25, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT (ITEM NUMBER 70102.8073) WAS DELIVERED AND THEN, IT WAS INVESTIGATED BY LABORATORY. THE BLUE CAP DID NOT FALL DOWN FROM THE SPIKE ITSELF, A SMALL AMOUNT OF FORCE WAS REQUIRED TO REMOVE IT. ALSO, THE DIAMETERS OF THE SPIKE AND CAP HAVE BEEN CONTROLLED AND ALL THE DATAS WERE WITHIN SPEC VALUES. THEREFORE, THE FAILURE WAS NOT CONFIRMED BY LABORATORY. THE AFFECTED PIECE PART IS NOT MANUFACTURED BY MCP. DEVICE HISTORY RECORD OF THE COMPLAINED LOT HAS BEEN INVESTIGATED AND NO ABNORMALITY WAS FOUND. A REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED. AN INTERNAL CLINICAL ASSESSMENT HAS BEEN PERFORMED BASED ON THE RECEIVED SIMILAR COMPLAINT REPORT. IT SEEMS THAT THIS INCIDENT HAS NOT BEEN A USER ERROR BUT RATHER A FAILURE OF THE SPIKE. SUMMARIZED IT COULD BE ADDED THAT THIS CASE IS NOT AS CRITICAL ASSESSED. A SAP TREND SEARCH HAS BEEN PERFORMED (SEARCH FOR MATERIAL 70105.1993 AND ISSUE: 1015 FALLING OFF PARTS) WHICH CAME TO FOLLOWING RESULTS: 3 ADDITIONAL COMPLAINTS WERE RECORDED.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "DURING THE PROCEDURE THE PROTECTIVE CAP THAT COVERS THE HOLE IN THE SPIKE CONNECTED TO THE CARDIOPLEGIA (ARTICLE (B)(4)) FALL APART GENERATING A LEAKAGE IN THE LINE." (B)(4).

    Description of Event or Problem · 1

    REF.: # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849709 HLM TUBING SET W/SOFTLINE COATING CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG BO-H 46700 92179785

    Patients

    Seq Age Sex Outcome Treatment
    1