BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25RWC W/ RES

    MDR report key: 16708290 · Received April 10, 2023

    Report

    Report Number
    1124841-2023-00085
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 19, 2023
    Report Date
    May 17, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450837
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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 APRIL 10, 20223 UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D3 (MANUFACTURER - CORRECTED EMAIL ADDRESS) D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXPIRATION DATE) G1 (CONTACT OFFICE - CORRECTED FIRST NAME, LAST NAME, EMAIL ADDRESS, TELEPHONE NUMBER) G3 (DATE RECEIVED BY MANUFACTURER) G6 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) H2 (FOLLOW-UP DUE TO CORRECTION AND ADDITIONAL INFORMATION) H4 (DEVICE MANUFACTURE DATE) 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 FOR EVALUATION; THEREFORE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE COMPLAINT DETAILS, THERE WAS EXCESSIVE VACUUM APPLIED TO THE RESERVOIR, SO THAT THE MAIN ARTERIAL BOOT LINE, (LEADING FROM THE RESERVOIR, THROUGH THE MAIN ROLLER PUMP AND TO THE INLET OF THE OXYGENATOR), BECAME STUCK AND AFFECTED PATIENT BLOOD PRESSURE AND BRAIN SATURATION. THE SITUATION WAS RESOLVED ONCE THE VACUUM WAS REMOVED FROM THE RESERVOIR. 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. H6: COMPONENT CODE: 4739 - GAS EXCHANGER. HEALTH EFFECT - IMPACT CODE: 2199 - NO HEALTH CONSEQUENCES OR IMPACT. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 2954 - IMPROPER FLOW OR INFUSION. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    THE BOOT LINE ON THE MAIN PUMP WAS STUCKED AND THE ROLER PUMP WAS RUNNING ON A VACUMMED LINE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE BOOT LINE ON THE MAIN PUMP WAS STUCK AND THE ROLER PUMP WAS RUNNING ON A VACUUMED LINE. AS PER THE USER FACILITY, WHILE THE PATIENT WAS ON BYPASS FOR AN ASCENDING AORTIC ANEURYSM; USING FEMORAL VENOUS CANNULA23 FOR MULTISTAGE AND USING VACUUM ASSISTED VENOUS DRAINAGE TO IMPROVE VENOUS RETURN, THE BOOT LINE ON THE MAIN PUMP WAS STUCK AND THE ROULER PUMP WAS RUNNING ON A VACUUMED LINE, WHICH AFFECT THE PATIENT BLOOD PRESSURE AND BRAIN SATURATION, UNTIL RELEASING THE VACUUMED ASSISTED VENOUS DRAINAGE. THERE WAS NO DELAY IN THE PROCEDURE, BUT AFFECT WAS ON THE PATIENT'S HEMODYNAMICS. THE PATIENT RECOVERED WITH NO FOLLOW-UP TREATMENT NEEDED. *NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783641 STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25RWC ZM18 00699753450837

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male