BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 17636366 · Received August 28, 2023

    Report

    Report Number
    1124841-2023-00205
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 3, 2023
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TERUMO HAS RECEIVED THE DEVICE FOR EVALUATION; HOWEVER, 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: 2645 - NO PATIENT INVOLVEMENT. HEALTH EFFECT - CLINICAL CODE: 4583 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 1120 - CONTAMINATION. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 - 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 AUGUST 28, 2023. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D4 (ADDITIONAL DEVICE INFORMATION - ADDED EXP DATE). 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). H4 (DEVICE MANUFACTURE DATE). H6 (IDENTIFICATION OF EVALUATION CODES 10, 11, 3331, 202, 3259, 4307). TYPE OF INVESTIGATION #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. TYPE OF INVESTIGATION #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. TYPE OF INVESTIGATION #3: 3331 - ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS #1: 202 - INAPPROPRIATE MATERIAL. INVESTIGATION FINDINGS #2: 3259 - IMPROPER PHYSICAL STRUCTURE. INVESTIGATION CONCLUSIONS: 4307- CAUSE TRACED TO COMPONENT FAILURE. THE RETURNED SAMPLE WAS INSPECTED UPON RECEIPT AND CONFIRMED TO HAVE A WHITE FOREIGN MATERIAL INSIDE THE POUCH BAG. HOWEVER, UPON CLOSER INSPECTION, WHERE THE FOREIGN MATERIAL WAS LOCATED IN THE BAG, THE BAG WAS NOTED TO HAVE A HOLE NEAR THE WATER PORT AREA AND ONE OF THE WATER PORTS WAS DAMAGED. ALSO, OF NOTE, THE MANUFACTURING PROCESS DOES NOT USE ANY TYPE OF WHITE POWDERY SUBSTANCE. 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE HAVE NOTICED A WHITE POWDERY SUBSTANCE INSIDE THE HEADER BAG. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    FOREIGN MATERIAL CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317633 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC 2M24 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown