BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 19945109 · Received August 8, 2024

    Report

    Report Number
    1124841-2024-00088
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    March 20, 2025
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    UDI-DI
    00699753527683
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED MALFUNCTION IS SPECIFIC TO DEVICE 3ZZ*FX15RE30CA LOT 3K14 THAT WAS MANUFACTURED INTO THE CONVENIENCE KIT REFERENCED IN D4. 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 11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G3 (DATE RECEIVED BY MANUFACTURER). G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT). H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION). H3 (DEVICE EVALUATED BY MANUFACTURER). H6 (IDENTIFICATION OF EVALUATION CODES 10, 3331, 3221, 4315). THE OXYGENATOR WAS INSPECTED UPON RECEIPT, NO SUBSTANCE WAS NOTED TO BE INSIDE OF THE UNIT. THE AFFECTED RESERVOIR WAS NOT RETURNED FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED REGARDING THE FILM BLOCKING THE LEVEL DETECTOR. WITHOUT THE RESERVOIR BEING RETURNED, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, 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 11. H3: EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, FOREIGN MATERIAL FILM BLOCKED THE LEVEL DETECTOR SIGNAL RESULTING TO THE PUMP DID NOT DETECT A LOW LEVEL EVEN WITH 0 VOLUME IN THE RESERVOIR ON A PEDIATRIC CASE. AS PER THE PERFUSIONIST, AFTER BYPASS, IT WAS NOTICED THAT THE BOTTOM OF THE VENOUS RESERVOIR HAD "SOMETHING" IN IT. THE SUBSTANCE THEN MOVED FROM THE BOTTOM OF THE RESERVOIR INTO THE OXYGENATOR. *NO CONSEQUENCES OR IMPACT TO PATIENT. *PRODUCT WAS CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703829 CARDIOVASCULAR PROCEDURE KIT N/A OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 75513-01 0000480427 00699753527683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown