BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 21594767 · Received March 13, 2025

    Report

    Report Number
    8010762-2025-0000111
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    March 5, 2025
    Report Date
    July 21, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWE
    UDI-DI
    04037691491882
    PMA / PMN Number
    K053025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    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 HIGH PRESSURE ACROSS THE MEMBRANE DURING THE TREATMENT WAS OCCURRED. CUSTOMER CHANGED THE PRODUCT DURING TREATMENT. NO HARM TO ANY PERSON WAS REPORTED. THE SAMPLE WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2025-07-08. A FLOW TEST WAS PERFORMED THAT RECORDS PRESSURE VALUES FOR BOTH ARTERIAL AND VEVNOUS SIDE OF OXYGENATOR. THERE COULD NOT BE FOUND ANY ABNORMALITIES DURING THE TEST. FURTHER, A VISUAL INSPECTION SHOWS NO DAMAGE OR VISIBLE CLOT FORMATION INSIDE OXYGENATION. BASED ON THIS, THERE COULD NOT BE FOUND ANY MALFUNCTION ON OXYGENATOR THAT COULD CAUSE THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS, THERE COULD NOT BE FOUND ANY FAILURE WITH THE PRODUCT ¿OXYGENATOR¿, THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE TECHNICAL CAUSE OF THE FAILURE. FURTHER, THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED QUADROX-I ADULT WITH LOT # 3000417645 WAS REVIEWED ON 2025-04-11 ACCORDING TO THE DHR RESULTS, THE PRODUCT QUADROX-I ADULT PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED HQV 7404#QUADROX "I" HL PACK WITH LOT# 3000435586 WAS REVIEWED ON 2025-03-17. ACCORDING TO THE DHR RESULT, THE PRODUCT HQV 7404#QUADROX "I" HL PACK PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. BASED ON THESE, COMPLAINT COULD NOT BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. 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 HIGH PRESSURE ACROSS THE MEMBRANE DURING THE TREATMENT WAS OCCURRED. CUSTOMER CHANGED THE PRODUCT DURING TREATMENT. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE WAS OCCURRED DURING TREATMENT AND A PRODUCT CHANGE WAS REQUIRED, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699749 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH HQV 7404 3000435586 04037691491882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other