BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS RX25RW OX W RES

    MDR report key: 11294609 · Received February 8, 2021

    Report

    Report Number
    1124841-2021-00016
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    May 20, 2021
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K153213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: D9 (DATE RETURNED TO MANUFACTURER) 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, 11, 3259, 4307) TYPE OF INVESTIGATION CODE#1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE TYPE OF INVESTIGATION CODE #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER INVESTIGATION FINDINGS: 3259 - IMPROPER PHYSICAL STRUCTURE INVESTIGATION CONCLUSIONS: 4307 - CAUSE TRACED TO COMPONENT FAILURE THE AFFECTED SAMPLE WAS INSPECTED UPON RECEIPT TO CONFIRM DAMAGED WATER PORTS. A REPRESENTATIVE RETENTION SAMPLE WAS INSPECTED TO CONFIRM NO DAMAGE TO THE UNIT, INCLUDING TO THE WATER PORTS. ALL CAPIOX UNITS ARE 100% VISUALLY INSPECTED AT SEVERAL POINTS IN THE PRODUCTION PROCESS. 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 ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON FEBRUARY 8, 2021. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6 (IDENTIFICATION OF EVALUATION CODES 3331, 4114, 3221, 4315). TYPE OF INVESTIGATION #1: 3331 - ANALYSIS OF PRODUCTION RECORDS. TYPE OF INVESTIGATION #2: 4114 - DEVICE NOT RETURNED. INVESTIGATION FINDINGS: 3221 - NO FINDINGS AVAILABLE. INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED. THE AFFECTED SAMPLE WAS NOT RETURNED SO A THOROUGH INVESTIGATION CANNOT BE PERFORMED AND A DEFINITIVE ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE DETERMINED. THE MANUFACTURING AND LEAK TEST RECORDS, FOR THE POTENTIAL LOTS, WERE REVIEWED AND NO ANOMALIES WERE NOTED. 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, THEY NOTICED A LEAKED WATER LINE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191900 NS RX25RW OX W RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*RX25RW YK24, YL14

    Patients

    Seq Age Sex Outcome Treatment
    1