BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX15REC W/ 4L RES

    MDR report key: 8172315 · Received December 17, 2018

    Report

    Report Number
    1124841-2018-00331
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 29, 2018
    Report Date
    February 1, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450813
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DECEMBER 17, 2018. (B)(4). IT WAS VERIFIED ON THE INVESTIGATION THAT THE INCORRECT OXYGENATOR WAS SHIPPED. A FAILURE IN PROCEDURE EXECUTION AS THE PICKER DID NOT PICK THE CORRECT ITEM AND THE PACKER NOR SHIPPER NOTED THE ERROR DURING THEIR VERIFICATION. IT WAS DETERMINED THAT THERE IS A DEFINED LOCATION IN THE DISTRIBUTION CENTER THAT INCLUDES PRODUCT ON PALLETS ON THE FLOOR AND THE INDICATED PRODUCT MOST LIKELY GOT INTERMINGLED WITH AN INCORRECT ITEM DURING PICKING. THE ROOT CAUSE WAS DISTRIBUTION CENTER MIXED EAST AND WEST CONFIGURED PRODUCTS WHEN RECEIVING AND PICKING ORDERS. 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. FOR THIS REASON, TERUMO REFERENCES EVALUATION CONCLUSION CODE. (B)(4). RESULTS: RESULTS PENDING COMPLETION OF INVESTIGATION. CONCLUSIONS: CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, CUSTOMER ORDERED WEST ORIENTATION OXYGENATORS BUT RECEIVED EAST ORIENTATION. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009748 STERILE FX15REC W/ 4L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX15RE40C WM29 00699753450813

    Patients

    Seq Age Sex Outcome Treatment
    1