BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY NT I-CVR 541T, STERILE

    MDR report key: 3935858 · Received July 15, 2014

    Report

    Report Number
    2184009-2014-00051
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 22, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE OXYGENATORS HAVE BEEN RECEIVED AT MEDTRONIC AND ARE CURRENTLY BEING CLEANED TO ALLOW BLOOD PERFORMANCE TESTING TO BE PERFORMED. UPON COMPLETION OF RETURNED PRODUCT ANALYSIS AND MEDTRONIC'S INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT SUBMITTED TO PROVIDE ANALYSIS AND INVESTIGATION INFORMATION. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO PHYSICAL DAMAGE OR ABNORMALITIES. THE DEVICE WAS CLEANED AND SUBJECT TO PERFORMANCE TESTING. PRESSURE INTEGRITY TESTING SHOWS NO INTERNAL OR EXTERNAL LEAKS WHEN RUN AT THREE LITERS/MINUTE WITH 23 PSIG OF BACK PRESSURE FOR TEN MINUTES. THE DEVICE WAS SENT TO THE BLOOD LAB FOR FURTHER PERFORMANCE TESTING. TESTING WAS CONDUCTED AT A 1:1 RATIO (7 LITERS/MINUTE BLOOD AND GAS FLOWS) AND THE RESULTS WERE COMPARED TO HISTORICAL TEST RESULTS OF OTHER USED TRILLIUM COATED AFFINITY NT OXYGENATORS. TESTING SHOWED THAT THE DEVICE PERFORMED AS EXPECTED WHEN COMPARED TO OTHER USED DEVICES. CONCLUSION: THE PRODUCT EVENT COULD NOT BE CONFIRMED BECAUSE THE DEVICE PERFORMED AS EXPECTED DURING PRODUCT RETURN ANALYSIS, INDICATING THAT THE DEVICE PERFORMANCE DID NOT CONTRIBUTE TO THE PRODUCT EVENT AND. UPDATED B1 TO ADVERSE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING A BYPASS PROCEDURE, AN ARTERIAL PO2 OF 50% WAS OBSERVED WITH A FIO2 OF 100% WHILE USING THIS AFFINITY NT HOLLOW FIBER OXYGENATOR. THE PERFUSIONIST REPLACED THE OXYGENATOR WITH A SECOND AFFINITY NT, BUT THE SAME ARTERIAL PO2 OF 50% WAS OBSERVED. THE SECOND DEVICE WAS USED FOR THE REMAINDER OF THE CASE. UPON COMPLETION OF THE CASE, THE PATIENT PRESENTED WITH SEVERE HYPOXEMIA AND ANEMIA. A BLOOD TRANSFUSION OF SEVEN UNITS WAS ADMINISTERED. THE PATIENT WAS TRANSFERRED TO AN INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. AS OF (B)(6) 2014, THE PATIENT REMAINED IN THE ICU WITH COAGULOPATHY AND ACUTE RENAL FAILURE. THE OXYGENATORS WERE RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413618 AFFINITY NT I-CVR 541T, STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ PERFUSION SYSTEMS 95215

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Hospitalization| L| R