BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLM TUBING SET W/SOFTLINE COATING

    MDR report key: 6083060 · Received November 7, 2016

    Report

    Report Number
    8010762-2016-00658
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 10, 2016
    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 PRODUCT IN QUESTION IS NOT AVAILABLE FOR MANUFACTURERS LABORATORY INVESTIGATION. A REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED. A SIMILAR COMPLAINT INVESTIGATION WAS FOUND WITH THE FOLLOWING RESULTS: THE PRODUCT WAS INVESTIGATED IN THE LABORATORY OF THE MANUFACTURER. THE BLUE CAPS AND THE FITTING ON THE SPIKES (2 EACH) WERE CHECKED FOR THEIR DIMENSIONS; NO ABNORMALITIES WERE FOUND THE DIMENSIONS WERE WITHIN TOLERANCE. DURING FUNCTIONAL EVALUATION IT WAS POSSIBLE TO REMOVE THE BLUE CAPS EASILY FROM THE SPIKES FITTING BY HAND. THE COMPLAINT DATA AND INVESTIGATION RESULTS WERE EVALUATED BY THE SUPPLIER MAQUET CARDIOPULMONARY (B)(4). A DHR REVIEW OF THE LOT AFFECTED WAS PERFORMED WITH NO ABNORMALITIES FOUND. NO SCRAP RECORD FOR THE RELATED MATERIAL WAS FOUND. THE SUPPLIER CONFIRMED DURING THE INVESTIGATION OF THE COMPLAINT SAMPLE THAT THE CAP WAS VERY EASILY REMOVABLE. THE MOST PROBABLE CAUSE OF THE FAILURE WAS DETERMINED AS MATERIAL FAILURE. NO BIG MEASUREMENT DIFFERENCE WAS FOUND. AS A CORRECTIVE ACTION, A SUPPLIER COMPLAINT HAS BEEN OPENED TO THE SUB SUPPLIER OF THE CAP. THE SUB SUPPLIER STATED THAT THE ASSEMBLY PROCESS OF THE CAP IS OUTSOURCED. IT WAS REQUESTED THAT THE SUB SUPPLIER IMPLEMENTS QUALIFICATION, TRAINING, PROCESS AND IN-PROCESS / FINAL CONTROLS. ALSO THE OPERATORS OF MAQUET (B)(4) HAVE BEEN INFORMED ABOUT THE COMPLAINT. BASED ON THE ABOVE MENTIONED FORMER INVESTIGATION RESULTS THE REPORTED PROBLEM COULD BE CONFIRMED. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER: "THE PERFUSIONISTS REALIZED THAT THE PROTECTIVE CAP OF THE HOLE IN THE SPIKE CONNECTED TO THE CARDIOPLEGIA ARTICLE 05008) HAD FALLEN APART AND THERE WAS A LEAKAGE IN THE LINE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735839 HLM TUBING SET W/SOFTLINE COATING CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG BO- H 46700 92174107

    Patients

    Seq Age Sex Outcome Treatment
    1