BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX05

    MDR report key: 10470483 · Received August 31, 2020

    Report

    Report Number
    9681834-2020-00175
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 31, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. PATIENT SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K) - K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALY INCLUDING A BREAKAGE IN THE APPEARANCE. THE ACTUAL OXYGENATION MODULE WAS FIXED BY BEING FILLED WITH GLUTARALDEHYDE-CONTAINING SALINE SOLUTION. THEN, THE HOUSING AND THE FILTER WERE REMOVED AND SUBJECTED TO VISUAL INSPECTION. FORMATION OF BLOOD CLOTS WAS FOUND ON BOTH THE OUTER AND INNER SURFACE OF THE FILTER. THE OXYGENATION MODULE WAS VISUALLY INSPECTED. PRESENCE OF BLOOD CLOT WAS OBSERVED. NO ANOMALY WAS NOTED IN THE STATE OF FIBER WINDING. THE FIBER LAYER WAS REMOVED GRADUALLY, AND THE STATE OF FIBER WINDING WAS INSPECTED. THERE WAS NOT ANY IRREGULARITY IN THE FIBER WINDING. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. NO ANOMALY SUCH AS AN OBSTRUCTION IN THE CHANNEL WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. THE PUMP RECORD WAS REVIEWED, HOWEVER, NO FACTORS THAT COULD LEAD TO THE PRESSURE RISE COULD BE READ FROM THE DATA. IFU STATES: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT IS LIKELY THAT A BLOOD-ORIGINATED CLOGGING MIGHT HAVE OCCURRED DUE TO A CHANGE IN BLOOD PROPERTIES, WHICH RESULTED IN THE PRESSURE RISE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX F05 WAS USED IN A REGULAR VSD CLOSURE CASE. PRESSURE AT THE OXYGENATOR INLET INCREASED UP TO 500MMHG. IN 30 MINUTES FROM THE START OF ECC, THE ACTUAL DEVICE WAS CHANGED OUT. CIRCULATION STOPPED FOR 20 MINUTES AND THEN RESTARTED. THE CASE SUCCESSFULLY FINISHED WITHOUT ANY FURTHER PROBLEM. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938167 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200323

    Patients

    Seq Age Sex Outcome Treatment
    1 Other