BEUDAMED
    FDA Adverse Event Death Summary report: N

    STERILE FX15RWC W/ 4L RES

    MDR report key: 10541773 · Received September 16, 2020

    Report

    Report Number
    1124841-2020-00223
    Event Type
    Death
    Date Received
    September 16, 2020
    Date of Event
    August 27, 2020
    Report Date
    November 3, 2020
    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

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    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 16, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: DESCRIBE EVENT OR PROBLEM - ADDED NEW INFORMATION). (DEVICE AVAILABILITY - ADDED DATE RETURNED TO MANUFACTURER). (DATE RECEIVED BY MANUFACTURER). (INDICATION THAT THIS IS A FOLLOW-UP REPORT). (TYPE OF REPORTABLE EVENT - ADDED NEW INFORMATION). (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). (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.) (EVENT PROBLEM AND EVALUATION CODES - PATIENT CODE). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    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: (ADDITIONAL DEVICE INFORMATION - ADDED EXPIRATION DATE). (DATE RECEIVED BY MANUFACTURER). (INDICATION THAT THIS IS A FOLLOW-UP REPORT). (FOLLOW-UP DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION). (DEVICE EVALUATED BY MANUFACTURER). (DEVICE MANUFACTURE DATE). VISUAL INSPECTION OF THE SAMPLE FOUND NO OBVIOUS ANOMALY THAT COULD LEAD TO POOR GAS TRANSFER PERFORMANCE. AFTER HAVING BEEN RINSED AND DRIED, IT WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE AND FOUND NO ANOMALIES AND MEET THE FACTORY SPECIFICATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED DROP OF OXYGENATION. PER USER FACILITY THE PATIENTS CAME IN WITH SEVERE RESPIRATORY INFECTION. HIS LVAD MALFUNCTIONED AND IT SEEMED BLOCKED SO THEY REPLACED IT WITH ANOTHER. THEY WENT ON BYPASS AT 14.21 H. OXYGENATION DROP AT 14.57 PM CO2 41 /PO2 78 CHANGE OUT OXYGENATOR AT 14.58PM AT FULL FLOW 257 PO2. FINISHED CASE AT 16.07 PM PCO2 =21, PO2=251 SEE CONNECT FILE FOR ALL DATA. NO CONSEQUENCES OR IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED INDICATING THAT ON (B)(6) 2020 THE PATIENT PASSED AWAY FROM SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004375 STERILE FX15RWC W/ 4L RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX15RW40C XK12 00699753450790

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR