BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSION TUBING SET

    MDR report key: 19674953 · Received July 4, 2024

    Report

    Report Number
    1718850-2024-00032
    Event Type
    Death
    Date Received
    July 4, 2024
    Date of Event
    June 5, 2024
    Report Date
    October 28, 2024
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    UDI-DI
    0803622128714
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: LIVANOVA USA INC. MANUFACTURES THE PERFUSION TUBING SET. THE INCIDENT OCCURRED IN (B)(6). ACCORDING TO MEDICAL OPINION, THE ISSUE OCCURRED WAS A USER ERROR, BECAUSE, WHEN PROTAMINE IS USED, THE GUIDELINE REQUIRES TO STOP ANY SUCK AND BLOOD CIRCULATION FROM THE FIELD. TO LEFT THE PROTAMINE IN AORTA FOR 1 HOUR AND 15 MINUTES IS NOT A STANDARD PROCESS. IN CASE OF NEED TO GO BACK ON BY-PASS THE HEPARIN SHALL BE PROVIDED TO THE PATIENT. MOST LIKELY THE PATIENT DIED FOR THE CRITICAL CONDITIONS INSTEAD OF DUE TO THE PROCEDURE PERFORMED. THEREFORE, THERE IS NO RELATIONSHIP BETWEEN THE PATIENT DEATH AND DEVICE MALFUNCTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H.11:NO OTHER INFORMATION ON EVENT NOR ON PART SHIPMENT WAS PROVIDED BY THE CUSTOMER AND PART WAS NEVER RECEIVED IN LIVANOVA ARVADA. MANUFACTURING PROCESS WAS REVIEWED AND OBSERVED THAT THE COMPLAINED CIRCUIT INCLUDED INSPIRE OXYGENATOR 6F THAT IS PHOSPHORYLCHOLINE COATED, WHICH FURTHER REDUCES THE ACTIVATION OF THE PATIENT'S BLOOD WHEN IT MEETS DEVICE SURFACES. TO GUARANTEE FULL AND HOMOGENEOUS DISTRIBUTION OF THE COATING SOLUTION, THE OXYGENATOR IS FIRST WASHED, THEN FILLED WITH COATING SOLUTION AND FINALLY DRIED. 100% VISUAL CHECK IS PERFORMED AT THE END OF THE DRYING PHASE TO VERIFY THE ABSENCE OF NON-CONFORMITY (I.E.: WET AREAS, DEPOSITS, OPACITY, AND/OR OTHER DEFECTS). THE OXYGENATOR IS ALSO WEIGHED BEFORE AND AFTER THE COATING TREATMENT TO ENSURE ADEQUATE DRYING. REVIEW OF THE DHR FOR INVOLVED LOTS OF PTS, OXYGENATOR AND RESERVOIR DID NOT REVEAL ANY NON-CONFORMITY NOR DEVIATION RELATED TO REPORTED ISSUE. COMPLAINTS DATABASE REVIEW DID NON REVEAL FURTHER SIMILAR COMPLAINTS FOR INVOLVED BATCHES, NEITHER SIMILAR ISSUES WERE IDENTIFIED THAT LED TO PATIENT'S DEMISE NOR A CONCERNING TREND WAS OBSERVED. BASED ON AVAILABLE INFORMATION, NO DEVICE MALFUNCTION WAS IDENTIFIED. THE ROOT CAUSE OF THE EVENT IS RELATED TO USER ERROR DURING CLINICAL PRACTICE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA USA INC. RECEIVED A REPORT THAT AFTER LEAVING THE AORTIC CANNULA IN THE AORTIC FOR 1 HOUR AND 15 MINUTES, AFTER PROTAMINE WAS FINISHED BEING GIVEN, AN ISSUE OCCURRED. THE CANNULA WAS PULLED OUT, BLOOD FROM AORTIC LINE DRAINED BACK INTO HIS SYSTEM AND IT WAS NOTED THAT CANNULA BEING IN THAT LONG IT GOT PROTAMINE INTO THE AORTIC LINE AND WAS SUCKED BACK INTO OXYGENATOR. WHEN THE USER ATTEMPTED TO GO BACK ON, THE AORTIC BLOOD THAT WAS SUCKED BACK INTO OXYGENATOR HAD CLOTTED. IT WAS FOUND GELATINOUS BLOOD AT THE OUTLET OF THE OXYGENATOR. THE ISSUE OCCURRED DURING SUPPORT. THE PATIENT DIED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270565 PERFUSION TUBING SET TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC. 044030600 2408500014 0803622128714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death