BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 10521804 · Received September 11, 2020

    Report

    Report Number
    1124841-2020-00218
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 25, 2020
    Report Date
    November 24, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Removal / Correction Number
    1124841-10/30/2020-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED DUE TO TERUMO CARDIOVASCULAR SYSTEMS ISSUING A FIELD REMOVAL, 1124841-10/30/2020-002-R. 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 SEPTEMBER 11, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: B5 (ADDED - DESCRIBE EVENT OR PROBLEM); D10 (DEVICE AVAILABILITY - ADDED DATE RETURNED TO MANUFACTURER); G4 (DATE RECEIVED BY MANUFACTURER) ; G7 (INDICATION THAT THIS IS A FOLLOW-UP REPORT); H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION); H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER); H7 (ADDED - IF REMEDIAL ACTION INITIATED); H9 (ADDED - FIELD REMOVAL NUMBER). A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. METHOD CODE #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. METHOD CODE #2: 3331 - ANALYSIS OF PRODUCTION RECORDS. RESULTS CODE: 170 - MANUFACTURING PROCESS PROBLEM IDENTIFIED. CONCLUSIONS CODE: 25 - CAUSE TRACED TO MANUFACTURING. THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM THE REPORTED EVENT. ROOT CAUSE ANALYSIS ACTIVITIES HAVE IDENTIFIED ASSOCIATE ERROR/FAILURE TO FOLLOW PROCEDURE AS THE IMMEDIATE CAUSE OF THE CONFIGURATION MIX-UP. AN ASSOCIATE PROVIDED THE INCORRECT CONFIGURATION OF OXYGENATOR TO THE ASSEMBLY LINE BY CHOOSING THE WRONG TOTE OF PRODUCT FROM A STAGING AREA AND THEN DIDN'T DETECT THE ERROR DURING DOWNSTREAM VISUAL INSPECTION. THIS EVENT HAS TRIGGERED A HEALTH HAZARD EVALUATION AND A CAPA IS IN PROCESS AND WILL IDENTIFY STRONGER CONTROLS FOR TOTE SELECTION AND DOWNSTREAM VERIFICATION WILL BE MANAGED VIA ENGINEERING CONTROLS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 0

    ON OCTOBER 30, 2020, TERUMO CARDIOVASCULAR SYSTEMS ISSUED A FIELD REMOVAL, 1124841-10/30/2020-002-R.

    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 DURING NON CLINICAL ACTIVITY, AN INCORRECT ASSEMBLY OF OXYGENATOR WAS RECEIVED. AS PER USER FACILITY, THE LABEL INDICATES 3CX*FX25RWC (WEST), BUT THE ACTUAL PACKED OXYGENATOR IS A 3CX*FX25REC (EAST). NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986509 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC YD16 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1