BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 13196668 · Received January 7, 2022

    Report

    Report Number
    1124841-2022-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Report Date
    February 25, 2022
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 JANUARY 7, 2022. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4: (ADDITIONAL DEVICE INFORMATION - ADDED EXP DATE). E1: (ADDRESS - UPDATED ESTABLISHMENT NAME). G3: (DATE RECEIVED BY MANUFACTURER). G6: (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2: (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H4: (DEVICE MANUFACTURE DATE). H6: (IDENTIFICATION OF EVALUATION CODES 11, 3331, 4114, 102, 4307). TYPE OF INVESTIGATION #1: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. TYPE OF INVESTIGATION #3: 4114 - DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 102 - INCOMPATIBLE COMPONENT/ ACCESSORY. INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE. THE AFFECTED SAMPLES WERE NOT RETURNED; HOWEVER, THE SHORT VIDEO PROVIDED CONFIRMED THAT THE TOP MOLDED PULP IS NOT PRESENT. IT ALSO APPEARS THAT THE BOX WAS OPENED AND RETAPED OUTSIDE THE TCV FACILITY. THE VISUAL APPEARANCE IS NOT ALIGNMENT WITH OUR PROCESS AND PROCEDURES A RETENTION SAMPLE OF THE SAME PRODUCT CODE AND LOT NUMBER WAS INSPECTED AND NOTED TO HAVE ALL COMPONENTS WITHIN THE BOX. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING OUT OF BOX, THE OXYGENATOR SHIPPING BOX DID NOT CONTAIN NORMAL PROTECTIVE PACKAGING. IT WAS DISCOVERED DURING RECEIVING PROCESS. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2517852 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC XA28 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown