BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 10771803 · Received November 2, 2020

    Report

    Report Number
    1124841-2020-00249
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 18, 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 TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION ADDED EXPIRATION DATE). 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 A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.) H4 (DEVICE MANUFACTURE DATE). 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 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 NOVEMBER 2, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: 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. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: G4 (DATE RECEIVED BY MANUFACTURER). G7 (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, 170, 25). 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 OUT OF BOX, THEY NOTICED THE IDENTIFICATION CODE DOESN'T CORRESPOND TO THE DEVICE INSIDE THE PACKAGE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235112 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC YD23 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1