BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NS RX25RW OX W RES

    MDR report key: 16992288 · Received May 24, 2023

    Report

    Report Number
    1124841-2023-00116
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 21, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K153213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 MAY 24,2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXP DATE) D9 (DEVICE AVAILABILITY - ADDED 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 EVALUATION ANTICIPATED BY MANUFACTURER) H4 (DEVICE MANUFACTURE DATE) H6 (IDENTIFICATION OF EVALUATION CODES 10, 3331, 11, 3259, 4307). TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE TYPE OF INVESTIGATION #2: 3331 - ANALYSIS OF PRODUCTION RECORDS TYPE OF INVESTIGATION #3: 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 RETURNED SAMPLE WAS INSPECTED UPON RECEIPT AND WAS CONFIRMED THAT THE ARTERIAL PIGTAIL LINE WAS PARTIALLY BROKEN OFF. A REPRESENTATIVE RETENTION SAMPLE WAS INSPECTED FOR DAMAGE WITH NO DAMAGE NOTED ON THE DEVICE. 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

    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. COMPONENT CODE: 4739- GAS EXCHANGER. HEALTH EFFECT ¿ IMPACT CODE: 2645- NO PATIENT INVOLVEMENT. HEALTH EFFECT ¿ CLINICAL CODE: 4582- NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 1354- LEAK/SPLASH. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    LEAKING OXYGENATOR.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A LEAKAGE ON THE OXYGENATOR. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509561 NS RX25RW OX W RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3ZZ*RX25RW 2F16

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown