BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 17696318 · Received September 7, 2023

    Report

    Report Number
    8010762-2023-00450
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 25, 2023
    Report Date
    October 10, 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

    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 AND THE PROVIDED PICTURES WITHIN THE COMPLAINT SHOW THE REPORTED FAILURE CLEARLY. BASED ON THIS, THE FAILURE COULD BE CONFIRMED. THE PRODUCTION HISTORY RECORDS (DHRS) OF THE AFFECTED BE-MECC 101403 WITH LOT# 3000315561 WAS REVIEWED ON 2022-09-11. 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¿. 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. ALL FURTHER STEPS WILL BE PERFORMED IN ACCORDANCE TO CAPA. BASED ON THE INVESTIGATION RESULTS, THE PROBABLE CAUSES HAVE BEEN FOUND AS: TRANSPORT / STATIONARY: UNKNOWN TRANSPORT CONDITIONS, MANUFACTURE FAILURE: LOOSE VELCRO STRAP CONNECTION BY MANUFACTURE EMPLOYEE, DESIGN FAILURE: SINGLE VELCRO STRAP USAGE IS NOT QUALIFIED FOR THE RELATED SET THEREFORE VELCRO STRAP BECOMES LOOSE. THE DETAILED ROOT CAUSE ANALYSIS WILL BE PERFORMED WITHIN 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINT # (B)(4).

    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 WAS REPORTED. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639951 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH CUSTOM TUBING SET 30000315561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other