BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 17773064 · Received September 19, 2023

    Report

    Report Number
    8010762-2023-00467
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    September 13, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT HOLE WAS FOUND ON TYVEK DURING UNPACKING THE PRODUCT AND THERE WAS NOT ANY DAMAGE DETECTED ON THE OUTER BOX (CARDBOARD BOX). THEREFORE, THE PRODUCT WAS NOT USED FOR TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE SAMPLE INVESTIGATION IS NOT REQUIRED AT THIS TIME. THE REPORTED FAILURE IS ALREADY KNOWN BY MANUFACTURER. BASED ON THIS, THE FAILURE COULD BE CONFIRMED. THE PRODUCTION HISTORY RECORDS (DHRS) OF THE AFFECTED BE-MECC 101403 WITH LOT# 3000321352 WAS REVIEWED ON 2023-10-25. ACCORDING TO THE DHR RESULTS, THE PRODUCT BE-MECC 101403 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. FURTHER, QUALITY HOLD HAS BEEN INITIATED FOR THE PRODUCT ¿BE-MECC 101403 / 701075208, V04¿. CAPA HAS BEEN INITIATED FOR THE REPORTED FAILURE ¿HOLE AT TYVEK / TYVEK PERFORATED¿ AND FOR THE REPORTED PRODUCT ¿BE-MECC 101403 / 701075208¿. THE ROOT CAUSE ANALYSIS AND FURTHER ACTIONS TO DETERMINE CORRECTIVE MEASURES FOR THE FAILURE WILL BE PERFORMED WITHIN THE CAPA. ROOT CAUSE INVESTIGATION HAS BEEN PERFORMED IN SCOPE OF CAPA. BASED ON THE INVESTIGATION RESULTS, MOST PROBABLE CAUSES HAVE BEEN DETERMINED AS: - ROOT CAUSE 1: WORSTCASE SELECTION DOESN¿T COVER TUBING SET QUADROX-IR CONFIGURATION WITH STANDARD TRAY. ALSO, QUADROX-I&ID ISN¿T ASSEMBLED TO RESERVOIR CONFIGURATION WITH STANDARD TRAY. - ROOT CAUSE 2: THERE IS NOT CLEAR REQUIREMENT DEFINED FOR EVALUATION OF PACKAGING CONFIGURATION IN SI-B-319 REV07 AND ITS FORM SHEETS. - ROOT CAUSE 3: THERE IS AN INADEQUATE SPECIFICATION/RULE FOR PACKAGING CONFIGURATION OF TUBING SET. - ROOT CAUSE 4: THERE IS INSUFFICIENT AWARENESS ABOUT EVALUATING THE SUITABILITY OF POSSIBLE CONFIGURATIONS IN TERMS OF PACKAGING OTHER THAN THE EXISTING DRAWINGS. - ROOT CAUSE 5: THE PROTECTIVE TUBE ASSEMBLED TO THE SHARP EDGE ON THE TOP OF QUADROX-IR DOES NOT PROVIDE SUFFICIENT PROTECTION. ALL FURTHER STEPS WILL BE PERFORMED IN ACCORDANCE TO THE CAPA THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HOLE WAS FOUND ON TYVEK DURING UNPACKING THE PRODUCT AND THERE WAS NOT ANY DAMAGE DETECTED ON THE OUTER BOX (CARDBOARD BOX). THEREFORE, THE PRODUCT WAS NOT USED FOR TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2097501 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH BE-MECC 101403#MECC SYSTEM W/O RESERVOIR 3000321352

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other