BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 12065289 · Received June 25, 2021

    Report

    Report Number
    9681834-2021-00116
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 25, 2021
    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. PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ANOMALY INCLUDING A BREAKAGE IN THE APPEARANCE. THE ACTUAL SAMPLE WAS FIXED BY BEING FILLED WITH GLUTARALDEHYDE-CONTAINING NORMAL SALINE, AND THEN THE HOUSING AND THE FILTER WERE REMOVED. VISUAL INSPECTION OF THE OXYGENATION MODULE FOUND FORMATION OF BLOOD CLOTS. THE OXYGENATION MODULE WAS VISUALLY INSPECTED WHILE THE FIBER LAYER WAS REMOVED GRADUALLY. FORMATION OF BLOOD CLOTS WAS OBSERVED THROUGHOUT THE OXYGENATION MODULE. NO ANOMALY WAS NOTED IN THE WOUND STATE OF FIBER. THE HEAT EXCHANGER WAS REMOVED FROM THE OUTER CYLINDER AND SUBJECTED TO VISUAL AND MAGNIFYING INSPECTIONS. FORMATION OF BLOOD CLOTS WAS OBSERVED THROUGHOUT THE HEAT EXCHANGER. ANY DEFORMITY THAT COULD CAUSE ANY OBSTRUCTION WAS NOT OBSERVED IN THE HEAT EXCHANGER. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. NO CAUSE OF PRESSURE RISE COULD BE READ FROM THE PUMP RECORD 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. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF NORMAL PRODUCT. IT IS LIKELY THAT BLOOD-DERIVED CLOGGING COULD HAVE OCCURRED DUE TO A COMBINATION OF THE CIRCULATION CONDITIONS (ACT, CIRCULATION TIME, ETC.) AND THE PATIENT'S BLOOD CONDITION, CAUSING THE PRESSURE TO RISE 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 THE CAPIOX DEVICE WAS USED DURING THE PROCEDURE. DURING INDUCTION OF ANESTHESIA, THE PATIENT WENT INTO ANAPHYLACTIC SHOCK AND THE BLOOD PRESSURE DROPPED, THEREFORE PUMP WAS STARTED WITH 570 SEC OF ACT. AT FIVE MINUTES AFTER THE PUMP STARTED, THE PRESSURE GRADIENT WAS 80 MMHG, AFTER COOLING STARTED, THE PRESSURE GRADUALLY INCREASED AND EXCEEDED 450 MMHG, THEN THE DECISION WAS MADE TO REPLACE THE OXYGENATOR; THE PRESSURE CONTINUED TO RISE DURING THE EXCHANGE THAT TOOK TEN MINUTES, AND REACHED 1000 MMHG. THE EXCHANGE OF OXYGENATOR WAS COMPLETED TWENTY MINUTES AFTER THE START OF THE PUMP, AND THEN THE PRESSURE GRADIENT REMAINED STABLE AROUND 70 MMHG UNTIL THE PUMP WAS OFF. PLATELETS WERE 500,000 BEFORE THE OPERATION, AFTER PUMP WAS OFF, IT WAS FOUND TO HAVE DECREASED TO 150,000. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME AS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966287 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other