BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 11997728 · Received June 15, 2021

    Report

    Report Number
    9681834-2021-00094
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 15, 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

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- CLINICAL ENGINEER. PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT BLOOD HAD ENTERED UP TO THE MIDDLE OF THE INLET SIDE OF THE OXYGENATOR SAMPLING LINE, THERE WAS NO EVIDENCE OF BLOOD INFLOW FARTHER. THE ACTUAL SAMPLE (AFTER RINSED AND DRIED) WAS BUILT INTO A CIRCUIT WITH TUBE AND FILLED WITH NORMAL SALINE COLORED FOR BETTER VISIBILITY, AND THEN CIRCULATED WHILE THE SAMPLING LINE WAS KEPT OPEN. AS A RESULT, THERE WAS NO FLUID FLOWING OUT FROM THE SAMPLING LINE. THE ADHESIVE PART OF THE OXYGENATOR AND THE SAMPLING LINE WAS CHECKED WITH A MAGNIFIER. AS THERE WERE FORCEPS MARKS ON THE SURFACE OF THE OXYGENATOR PORT, IT WAS NOT POSSIBLE TO OBSERVE THE INSIDE OF THE BLOOD FLOW CHANNEL IN DETAIL. THE BLOOD OUTLET PORT OF THE OXYGENATOR WAS CUT AT ITS BASE, THE TUBE ADHESION AREA WAS CHECKED UNDER X-RAY FLUOROSCOPE, AND A FILM WAS FOUND TO HAVE FORMED INSIDE THE TUBE NEAR THE BASE OF THE ADHESION AREA. THE BLOOD OUTLET PORT OF THE ACTUAL SAMPLE WAS SPLIT IN HALF, AND THE APPEARANCE OF THE FILM WAS CHECKED FROM THE INNER SIDE OF THE PORT USING A MAGNIFIER. IT WAS CONFIRMED TO BE TRANSLUCENT. THE FILM WAS COLLECTED AND QUALITATIVELY ANALYZED BY FOURIER TRANSFORM INFRARED SPECTROSCOPY (FT-IR). THE SPECTRA OF THE FILM WERE FOUND TO BE SIMILAR TO THE SYNTHETIC SPECTRA OF THE TUBE PLASTICIZER AND THE ACRYLIC RESIN THAT MAY HAVE BEEN DERIVED FROM THE SOLVENT USED FOR TUBE ADHESION. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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 WAS LIKELY THAT DURING THE ADHESION PROCESS OF TUBE AND OXYGENATOR PORT, THE SOLVENT REMAINED INSIDE THE TUBE SOLIDIFIED INTO A FILM BEFORE COMPLETELY REMOVED, WHICH RESULTED IN CLOGGING THE TUBE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AFTER A CLEAR PRIMING OF THE CAPIOX FX05 DEVICE, THEY TRIED TO START A BLOOD PRIMING, ALTHOUGH FOUND THAT THE BLOOD DID NOT PASS THROUGH THE SAMPLING LINE, SO DEAIRING WAS NOT POSSIBLE. SINCE THERE WAS STILL TIME TO SPARE BEFORE PUMP-ON, THEY REPLACED THE OXYGENATOR IN QUESTION WITH ANOTHER ONE. AFTER THAT, NO FURTHER PROBLEMS OCCURRED. BEFORE DEVICE WAS USED ON THE PATIENT, THE OXYGENATOR WAS REPLACED WITH ANOTHER NEW ONE. THERE WERE NO PROBLEMS AFTER THE REPLACEMENT. DURING PREPARATION, THE OXYGENATOR WAS REPLACED AS IT WAS JUDGED TO BE CLOGGED BECAUSE IT COULD NOT BE PRIMED DUE TO POSSIBLE DEFECT IN THE SAMPLING LINE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901331 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other