BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HEMOCONCENTRATOR

    MDR report key: 8037739 · Received November 5, 2018

    Report

    Report Number
    9681834-2018-00198
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 5, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER- IT WAS REPORTED THE LOT NUMBER COULD POTENTIALLY BE 171211 OR 171226 D4: EXPIRATION DATE - BOTH POTENTIAL LOT NUMBERS REPORTED HAVE THE EXPIRATION DATE OF NOVEMBER 30, 2020 D6: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED H4: DEVICE MANUFACTURE DATE- LOT#171211 IS DECEMBER 11, 2017 AND OF LOT#171226 IS DECEMBER 26, 2017 THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. HOWEVER, PICTURES SHOWING THE STATE OF THE COMPLAINT WERE PROVIDED. REVIEW OF THE PROVIDED PICTURES REVEALED, THE FILTRATE WAS FOUND TO HAVE BEEN DYED RED. THE RETENTION SAMPLES OF THE COMBINATION OF THE INVOLVED PRODUCT CODE/LOT#171211 AND /LOT#171226 WERE INSPECTED AND VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS ANOMALY, SUCH AS A BREAK, IN THE APPEARANCE. THE RETENTION SAMPLE WAS BUILT INTO A CIRCUIT WITH TUBES, WHERE BOVINE BLOOD (37OC, HCT25%) WAS LET TO FLOW THROUGH THE CIRCUIT. BLOOD WAS CONFIRMED TO RUN THROUGH IT WITH NO DIFFICULTY WITH NO GENERATION OF A LEAK OR NO CHANGE IN THE COLOR OF THE FILTRATE INTO RED. BOVINE BLOOD WAS LET TO FLOW THROUGH THE CIRCUIT AND THE PRESSURE LOSS WAS DETERMINED. THE OBTAINED VALUE WAS CONFIRMED TO MEET THE SPECIFICATIONS. THE ULTRAFILTRATION PERFORMANCE WAS DETERMINED AND VERIFIED TO MEET THE SPECIFICATIONS. AS A REASON OF THE ACTUAL SAMPLE'S SPONTANEOUS RECOVERY OF ITS NORMAL FUNCTION, BASED ON EXPERIENTIAL KNOWLEDGE, IT IS LIKELY THAT THE IMPLEMENTATION OF DIRECT PRIMING INDUCED TEMPORARY HEMOLYSIS AT THE INITIATION OF FILTERING. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: A FEW MINUTES MAY BE NECESSARY UNTIL THE FILTRATE PHASE AND FILTRATE LINE ARE FILLED AT THE INITIATION OF ULTRAFILTRATION. STOP USING THE HEMOCONCENTRATOR IF BLOOD LEAKAGE, CLOTTING OR ANY OTHER PROBLEM IS OBSERVED. REPLACE IT WITH A NEW ONE. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE IT TOOK THE CARDIOVASCULAR HEMOCONCENTRATOR A LITTLE MORE TIME TO START FILTERING. IT ALLOWED ERYTHROCYTES TO PASS TO THE WASTE LIQUID, AND THEN LATER THE HEMOCONCENTRATOR WAS REGULARIZED. THE EVENT OCCURRED DURING ANOTHER PROCEDURE, A CORONARY REVASCULARIZATION. THE SURGERY WAS DELAYED FOR TEN MINUTES MORE THAN THE NORMAL AVERAGE TIME. THE PATIENT WAS OK AFTER THE SURGERY, AND THERE WERE NO COMPLICATIONS LATER. THE DEVICE RECOVERED TO ITS NORMAL FUNCTION ON ITS OWN, THAT IS WHY IT WAS NOT CHANGED OUT, THE DESCRIBED INCIDENT TOOK PLACE INITIALLY AND THEN IT RECOVERED ALONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879513 CAPIOX HEMOCONCENTRATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA

    Patients

    Seq Age Sex Outcome Treatment
    1