BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 21374751 · Received February 13, 2025

    Report

    Report Number
    3017987980-2025-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 29, 2025
    Report Date
    September 12, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR COSTA RICA LLC
    Product Code
    OEZ
    UDI-DI
    00699753521704
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE USER FACILITY, THE HEMOCONCENTRATOR USED TO BE 1/4 AND SEALED OUTSIDE, AND THE LOT THEY HAD WAS 3/16 AND SEALED ON THE INSIDE BUT NOT SEALED CORRECTLY.

    Additional Manufacturer Narrative · 0

    UPDATED BLOCKS: B5 AND H6 THE REPORTED COMPLAINT WAS CONFIRMED. DURING FURTHER INVESTIGATION OF THE PHOTO PROVIDED, THE REPORTED COMPLAINT WAS CONFIRMED. THE COMPLAINT INFORMATION AND EVIDENCE PROVIDED INDICATED THAT THE ISSUE OCCURRED ON LINE 1 OF THE DRAWING SPECIFICATION, WHERE THE INCORRECT TYPE OF TUBING WAS USED CAUSING A LEAK BETWEEN THE CONNECTION OF L3 AND THE CONNECTOR 080189. THE INTERACTION BETWEEN THE CONNECTOR 080189 AND THE 4.75X1.0 TUBING WAS RECREATED TO UNDERSTAND IF THIS COULD HAVE PLAYED A FACTOR IN THE ISSUE REPORTED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE DUE TO WORKMANSHIP WHERE THE 4.75X1.0 TUBING WAS USED ON THE L1 OR L3 INSTEAD OF THE SPECIFIED 1/4X1/16 TUBING, RESULTING IN A LEAK. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEMOCONCENTRATOR WAS FOUND NOT TO BE SEALED CORRECTLY, CAUSING A LEAK AT THE CONNECTION. AS A RESULT, ANOTHER HEMOCONCENTRATOR FROM THE SAME LOT WAS EMPLOYED BUT THE SAME ISSUE OCCURRED. THE HEMOCONCENTRATOR WAS REPLACED AGAIN WITH ONE FROM A DIFFERENT LOT AND THE ISSUE WAS RESOLVED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A DELAY OF AN UNKNOWN AMOUNT. THERE WERE APPROXIMATELY 200 MILLILITERS (ML) OF BLOOD LOSS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    PER CLINICAL REVIEW: THIS COMPLAINT INVOLVED A TUBING PACK AND THE HEMOCONCENTRATOR AND TUBING LINE CONNECTED TO IT, THAT LEAKED BLOOD DURING CARDIOPULMONARY BYPASS (CPB). THE HEMOCONCENTRATOR AND TUBING LINE WAS CHANGED OUT WITH A NEW DISPOSABLE FROM THE SAME LOT, AND THE LEAK RE-OCCURRED. NEW DISPOSABLES FROM A DIFFERENT LOT NUMBER WERE THEN USED TO PERFORM ANOTHER CHANGEOUT AND THE ISSUE RESOLVED. THE COMPLAINT DISPOSABLES WERE NOT RETURNED, BUT PICTURES AND VIDEO WERE SHARED THAT CONFIRMED THE BLOOD LEAK DURING CPB. THERE WAS APPROXIMATELY 200 CUBIC CENTIMETER (CC) OF BLOOD LOSS TO THE PATIENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637800 TERUMO CARDIOVASCULAR PROCEDURE KIT CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR COSTA RICA LLC CX-SP162 0000638613 00699753521704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown