BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX15RWC W/ 4L RES

    MDR report key: 14497975 · Received May 25, 2022

    Report

    Report Number
    1124841-2022-00116
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 5, 2022
    Report Date
    July 8, 2022
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450790
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. (B)(4) - GAS EXCHANGER. HEALTH EFFECT - (B)(4) - NO HEALTH CONSEQUENCES OR IMPACT. HEALTH EFFECT - (B)(4) - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. (B)(4) - USE OF DEVICE PROBLEM. (B)(4) - RESULTS PENDING COMPLETION OF INVESTIGATION. (B)(4) - CONCLUSION NOT YET AVAILABLE.

    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 25, 2022. 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 SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY. SINCE THE ACTUAL PRODUCT AND THE MANUFACTURING RECORDS COULD NOT BE INVESTIGATED, THE CAUSE OF THE OCCURRENCE COULD NOT BE CLARIFIED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS INADEQUATE MEMBRANE OXYGENATION. THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR GROUP THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ADEQUATE MEMBRANE OXYGENATION WITH PARAMETERS THAT EVIDENCE TO A LOW PO2 IN EXTRACORPOREAL CIRCULATION WITH A FLOW RATE BETWEEN LIMIT. MANY CHANGES IN FIO2, AND ARTERIAL FLOW TO SUPPORT THE LOW OXYGENATION. THE LOCATION OF THE HOSPITAL HAS AN ALTITUDE OF 2850 METERS OVER SEA LEVEL AND HIGH ATMOSPHERIC PRESSURE. THE PERFUSIONIST BELIEVES THAT THE LOW OXYGEN DELIVERY IS DUE TO THE ATMOSPHERIC PRESSURE AND HIGH LEVEL CITY. *NO CONSEQUENCE OR IMPACT TO THE PATIENT . *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285954 STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX15RW40C ZK30 00699753450790

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown