BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX15REC W/ 4L RES

    MDR report key: 9949459 · Received April 10, 2020

    Report

    Report Number
    1124841-2020-00089
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    March 23, 2020
    Report Date
    May 20, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450813
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON APRIL 10, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXP DATE). D10 (DEVICE AVAILABILITY - ADDED DATE RETURNED TO MANUFACTURER). G4 (DATE RECEIVED BY MANUFACTURER) . G7 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) . H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION) . H3 (DEVICE EVALUATED BY MANUFACTURER) . H4 (DEVICE MANUFACTURE DATE). H6 (IDENTIFICATION OF EVALUATION CODES 10, 11, 3331, 202, 4307). METHOD CODE #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. METHOD CODE #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. METHOD CODE #3: 3331 - ANALYSIS OF PRODUCTION RECORDS. RESULTS CODE: 202 - INAPPROPRIATE MATERIAL. CONCLUSIONS CODE: 4307 - CAUSE TRACED TO COMPONENT FAILURE. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT WITH NO VISUAL ANOMALIES NOTED. THE ONE WAY VALVE WAS OBSERVED TO BE ORIENTED IN THE CORRECT DIRECTION. WATER WAS FLOW THROUGH THE LINE WHERE IT APPEARED TO FLOW LESS THAN EXPECTED. FURTHER INVESTIGATION FOUND A BLOCKAGE IN THE L SHAPED CONNECTOR. THE BLOCKAGE WAS CLEARED, HOWEVER, THE MATERIAL WAS NOT ABLE TO BE RECOVERED. ONCE THE BLOCKAGE WAS CLEARED, THE TUBING FLOWED AS EXPECTED. A REPRESENTATIVE RETENTION SAMPLE WAS INSPECTED WITH WATER AND IT WAS FOUND TO FLOW AS EXPECTED. THE SUPPLIER OF THIS COMPONENT WAS NOTIFIED OF THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, THEY NOTICED THAT THE SAMPLE LINE ATTACHED TO MANIFOLD ON OXYGENATOR WOULD NOT ALLOW FLOW WHILE PRIMING CIRCUIT. AS PER THE USER FACILITY, THEY VISUALLY CHECKED OF ONE WAY VALVE AND IT WAS IN BACKWARDS. THEY OPENED ANOTHER OXYGENATOR AND USED LINE FROM THAT UNIT. LINE WAS CHANGED OUT USING LINE FROM ANOTHER FX15 ON THE SHELF. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412329 STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX15RE40C XP09 00699753450813

    Patients

    Seq Age Sex Outcome Treatment
    1