BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE FX25REC W/RES

    MDR report key: 10771924 · Received November 2, 2020

    Report

    Report Number
    1124841-2020-00251
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    January 21, 2021
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    UDI-DI
    00699753450820
    PMA / PMN Number
    K151791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NOVEMBER 2, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: D10 (DEVICE AVAILABILITY ADDED DATE RETURNED TO MANUFACTURER). G4 (DATE RECEIVED BY MANUFACTURER). G7 (INDICATION THAT THIS IS A FOLLOW-UP REPORT) . H2 (FOLLOW-UP DUE TO ADDITIONAL INFORMATION). H3 (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 CONCLUSIONS CODE 11). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    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: H6 (IDENTIFICATION OF EVALUATION CODES 925, 2645, 4582, 1503, 10, 11, 114, 4315). COMPONENT CODE: 925 - PUMP. HEALTH EFFECT - IMPACT CODE: 2645 - NO PATIENT INVOLVEMENT. HEALTH EFFECT - CLINICAL CODE: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. MEDICAL DEVICE PROBLEM CODE: 1503 - PUMPING STOPPED. 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. INVESTIGATION FINDINGS: 114 - OPERATIONAL PROBLEM IDENTIFIED. INVESTIGATION CONCLUSIONS: 4315 - CAUSE NOT ESTABLISHED. A VISUAL INSPECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY ANOMALY INCLUDING A BREAKAGE. THE ACTUAL SAMPLE WAS INSTALLED INTO A CIRCUIT CONSISTING OF TUBES, CLAMPED BY A ROLLER PUMP THAT STOPPED THE BLOOD INLET SIDE OF THE OXYGENATOR, AND WATER WAS CIRCULATED TO THE WATER CHANNEL WITH THE SALINE SOLUTION FILLED HALFWAY THROUGH THE LINE CONNECTING TO THE BLOOD OUTLET PORT. NO FLUCTUATION IN THE LIQUID LEVEL WERE OBSERVED. AFTER INVESTIGATION RESULT, BY CHANGING THE CLAMP STATE OF THE TUBE CONNECTED TO THE WATER PORT, THE CIRCULATION PRESSURE OF THE WATER CHANNEL WAS CHANGED. IT WAS CONFIRMED THAT THE FLUCTUATION OF THE LIQUID LEVEL WAS REPRODUCED. IN ADDITION, IT WAS CONFIRMED THAT THE SAME FLUCTUATION OF THE LIQUID LEVEL WAS REPRODUCED IN THE FACTORY-RETAINED OXYGENATOR. AFTER CONNECTING THE FACTORY-RETAINED TUBE TO THE ACTUAL SAMPLE, THE WATER CHANNEL WAS FILLED WITH WATER (COLORED TO IMPROVE VISIBILITY), THE TUBE CONNECTED TO THE WATER OUTLET PORT WAS CLAMPED WITH FORCEPS AND PRESSURE OF 3 KGF / CRN 2 WAS APPLIED FROM THE WATER INLET SIDE FOR 6 HOURS. NO LEAKAGE WAS OBSERVED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    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).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE PUMP STOPPED WITH THE THERMOCIRCULATOR(HEATER COOLER DEVICE)RUNNING. PER SUBSIDIARY "DURING THE OCCLUSION PHASE OF THE MASTER WITH THE PUMP STOPPED WITH THE THERMOCIRCULATOR RUNNING, THE CUSTOMER NOTICED THAT THE LEVEL OF THE PRIME IN THE ARTERIAL LINE OSCILLATED AS IF THERE WAS A BOOST PRESSURE ON THE ARTERY. NO PATIENT INVOLVEMENT. THERE WAS 45 MINUTES DELAY IN THE PROCEDURE. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237435 STERILE FX25REC W/RES BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CX*FX25REC YC17 00699753450820

    Patients

    Seq Age Sex Outcome Treatment
    1