BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 8282777 · Received January 28, 2019

    Report

    Report Number
    1124841-2019-00023
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 10, 2019
    Report Date
    March 7, 2019
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 JANUARY 28, 2019. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: ADDITIONAL DEVICE INFORMATION - ADDED EXP DATE; DATE RECEIVED BY MANUFACTURER; INDICATION THAT THIS IS A FOLLOW-UP REPORT; FOLLOW-UP DUE TO ADDITIONAL INFORMATION; DEVICE MANUFACTURE DATE; IDENTIFICATION OF EVALUATION CODES 4114, 3331, 11, 3259, 4307. METHOD CODE #1: 4114 - DEVICE NOT RETURNED; METHOD CODE #2: 3331 - ANALYSIS OF PRODUCTION RECORDS; METHOD CODE #3: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER; RESULTS CODE: 3259 - IMPROPER PHYSICAL STRUCTURE; CONCLUSIONS CODE: 4307 - CAUSE TRACED TO COMPONENT FAILURE. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A RETENTION SAMPLE FROM THE SAME PRODUCT CODE AND LOT NUMBER COMBINATION WAS VISUALLY INSPECTED AND FOUND TO HAVE NO DAMAGES OR ANOMALIES, SPECIFICALLY WITH THE RESERVOIR LID. ALL RESERVOIRS ARE 100% VISUALLY INSPECTED AT SEVERAL POINTS IN THE PRODUCTION PROCESS. THE PACKAGING OF THE PRODUCT ALSO ENSURES PROTECTION AGAINST DAMAGE TO THE RESERVOIR AND ITS COMPONENTS DURING SHIPPING. IT IS LIKELY THAT THE RESERVOIR WAS DAMAGED BY A SHOCK FORCE AT SOME POINT DURING THE HANDLING OF THE PRODUCT, HOWEVER, WHEN OR HOW THIS SHOCK FORCE WAS APPLIED WAS NOT ABLE TO BE DETERMINED. 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, DURING SETUP, A CRACK ON TOP OF RESERVOIR WAS NOTED. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75140 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC WK20 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1