BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 12427148 · Received September 6, 2021

    Report

    Report Number
    8010762-2021-00484
    Event Type
    Malfunction
    Date Received
    September 6, 2021
    Date of Event
    August 19, 2021
    Report Date
    December 16, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K150267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DUE TO INCREASING RESISTANCE PRESSURE IN QUADROX-ID ADULTS THE OXYGENATOR WAS EXCHANGED SEVERAL TIMES DURING TREATMENT. NO HARM OR DEATH WAS REPORTED. IT WAS ALSO REPORTED THAT THE OXYGENATORS WERE USED IN VA-ECLS WITH LIMITED USE OF HEPARIN AND ACTS AROUND 150'', BLOOD FLOW WAS BETWEEN 3-4 LPM. THE PRODUCTS ARE NOT AVAILABLE FOR INVESTIGATION IN THE LABORATORY OF MANUFACTURER. IT WAS REPORTED THAT THE OXYGENATORS WERE STARTED TO RESIST AT THE BELOW TIMES: ON 2021-08-19: INCREASING RESISTANCES 07H 16H 19H THEN CHANGE OF OXYGENATOR; ON 2021-08-20: INCREASING RESISTANCES 07H 17H 21H 23H THEN CHANGE OXYGENATOR; ON 2021-08-23: INCREASING RESISTANCES 07H 15H THEN CHANGE OXYGENATOR. CUSTOMER OBSERVED THAT THE OXYGENATORS STARTED TO SHOW A RESISTANCE AFTER 7 HOURS OF USAGE. THE INFORMATION RECEIVED BY GETINGE SALES AND SERVICE SUPPORT RESPONSIBLE CONFIRMS THAT REPORTED THAT OXYGENATORS WERE USED LONGER THAN 6 HOURS. ON 2021-08-19: USED FOR 19H; ON 2021-08-20: USED FOR 23H; ON 2021-08-23: USED FOR 15H. IFU STATES THE MAXIMUM DURATION OF USE IS 6 HOURS. THE DEVICE HISTORY RECORDS FOR LOT NUMBER 92311132 FOR FIRST BE-HQV 30517 AND LOT NUMBER 3000165035 FOR THIRD BE-HQV 30517 WERE REVIEWED ON 2021-11-16. THERE ARE NO EVIDENCES INDICATING NON-CONFORMANCE OR DEVIATIONS OF THE PRODUCT IN QUESTION DURING MANUFACTURING AND FINAL RELEASE OF THIS SPECIFIC LOT. THE LOT NUMBER FOR THE SECOND BE-HQV 30517 WAS NOT PROVIDED BY THE CUSTOMER, THEREFORE NO DHR REVIEW COULD BE PERFORMED. THE DEVICE HISTORY RECORDS FOR ALL THREE OXYGENATORS COULD NOT BE REVIEWED BECAUSE THE SERIAL NUMBERS ON THE OXYGENATORS WERE NOT PROVIDED BY THE CUSTOMER. IT WAS FURTHER REPORTED THAT ACTS WERE AROUND 150''. HOWEVER THE IFU FOR (PRODUCT XXX) STATE THAT THE ACT SHOULD NOT FALL BELOW 450 S. THE ANTICOAGULATION AMOUNT WAS NOT PROVIDED BY THE CUSTOMER, BUT IT WAS REPORTED AS ¿LIMITED USE OF HEPARIN¿. BASED ON THE INFORMATION ABOVE, THE MOST PROBABLY USE(R) ERROR CONTRIBUTED TO THE FAILURE. NO PRODUCT MALFUNCTION COULD BE DETECTED WITH AVAILABLE INFORMATION HOWEVER THE COMPLAINT COULD BE CONFIRMED SINCE IT WAS DETECTED DURING PATIENT USE AND CUSTOMER HAD TO CHANGE THE DEVICES. 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. H3 OTHER TEXT : 4115.

    Description of Event or Problem · 0

    COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER PERFUSION AND PATIENT DATA WAS REQUESTED BUT NOT YET RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INCREASING RESISTANCE OF THREE OXYGENATORS IN A ROW NEEDING REPLACEMENT DURING TREATMENT. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324673 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HQV 30517 3000165035 & 92311132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown