BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VKMO 78000

    MDR report key: 5637041 · Received May 6, 2016

    Report

    Report Number
    8010762-2016-00320
    Event Type
    Malfunction
    Date Received
    May 6, 2016
    Date of Event
    March 8, 2016
    Report Date
    April 13, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    PMA / PMN Number
    K102919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET WITH RESERVOIR AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE RESERVOIR WHICH IS REGISTERED UNDER 510(K): K102919.

    Additional Manufacturer Narrative · 1

    THE RESULT OF OUR ANALYSIS OF THIS COMPLAINT FROM (B)(6): THE PROBABLE ROOT CAUSES COULD BE DETERMINED AS A MATERIAL FAILURE AND DESIGN FAILURE. DEVICE HISTORY RECORDS OF THE COMPLAINED LOT HAS BEEN REVIEWED AND NO ABNORMALITY WAS FOUND FOR THE RELATED MATERIAL. MOREOVER, NO SCRAP RECORD FOR THE RELATED MATERIAL WAS FOUND. THE CRACK ON THE TEMPERATURE PROBE COULD BE RELATED WITH WEAKNESS OF THE MATERIAL. ON THE OTHER HAND, IT COULD BE POSSIBLE THAT THE OPERATOR COULD TIGHTEN THE TEMPERATURE PROBE REGARDLESS OF THE TORQUE SETTINGS. THUS, BASIC OPERATION PROCEDURE RELATED WITH THE TORQUE VALUES SHOULD BE REVISED. AS A CORRECTIVE ACTION, FOR THE PREVIOUS COMPLAINTS REGARDING TO THE SAME FAILURE, WE HAD OPENED CAPA (B)(4) AND ALL ACTIONS WILL BE FOLLOWED BY CAPA (B)(4). ALSO, OUR OPERATORS HAVE BEEN INFORMED WITH REGARD OF THE COMPLAINT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE SIDE CONNECTION ON THE INLET OF THE RESERVOIR (TEMPERATURE PROBE) WAS BROKEN DOWN. THE RESERVOIR HAD TO BE REPLACED DURING TREATMENT - NO SEVERE DELAY FOR THE TREATMENT. NO KNOWN CONSEQUENCES TO THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292673 VKMO 78000 FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM MAQUET CARDIOPULMONARY AG 92159713

    Patients

    Seq Age Sex Outcome Treatment
    1