BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 11730610 · Received April 27, 2021

    Report

    Report Number
    9681834-2021-00072
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 27, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE BLOOD INLET PORT HAD BEEN FRACTURED AT THE ROOT. NO BREAK, NO DEFORMITY, OR NO OTHER EXTERNAL ANOMALY WAS OBSERVED AROUND THE BLOOD INLET PORT. THE HOUSING OF THE BLOOD INLET PORT SIDE WAS REMOVED, THEN THE ROOT OF THE BLOOD INLET PORT WAS INSPECTED UNDER A MAGNIFIER. NO CRACK, NO DEFORMITY, OR NO OTHER EXTERNAL ANOMALY WAS OBSERVED AROUND THE ROOT OF THE BLOOD INLET PORT. THE FRACTURE SURFACE WAS INSPECTED UNDER A MAGNIFIER AND FOUND SMOOTH OVER THE ENTIRE AREA. STREAKY PATTERN THAT HAD DEVELOPED RADIALLY FROM A POINT BETWEEN THE BOTTOM SIDE AND FRONT SIDE OF THE OXYGENATOR WAS OBSERVED ON THE FRACTURE SURFACE. MAGNIFYING INSPECTION AROUND THE ESTIMATED START POINT OF THE RADIAL STREAKY PATTERN FOUND WAVY PATTERN CROSSING THE STREAKY PATTERN. BASED ON THE ABOVE, IT WAS LIKELY THAT AN INSTANTANEOUS LOAD WAS EXERTED ON THE BLOOD INLET PORT FROM THE DIRECTION BETWEEN THE FRONT SIDE AND THE BOTTOM SIDE OF THE OXYGENATOR. THE FRACTURE OF THE BLOOD INLET PORT SEEMED TO HAVE STARTED FROM THE CENTRAL POINT OF THE WAVY PATTERN AND DEVELOPED IN THE DIRECTION OF THE STREAKY PATTERN. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. 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 THE BLOOD INLET PORT WAS SUBJECTED TO A SHOCK LOAD FROM THE DIRECTION BETWEEN THE FRONT SIDE AND THE BOTTOM SIDE OF THE OXYGENATOR, RESULTING IN THE FRACTURE. SINCE NO ANOMALY WAS NOTED IN THE MANUFACTURING-RELATED RECORDS, IT WAS PRESUMED THAT THE ACTUAL SAMPLE WAS SUBJECTED TO A SHOCK LOAD UNEXPECTEDLY AT SOME POINT DURING TRANSPORTATION OR STORAGE. FROM THE AVAILABLE INFORMATION INCLUDING THE STATE OF THE ACTUAL SAMPLE, HOWEVER, THE SPECIFIC TIMING COULD NOT BE DETERMINED. 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 CAPIOX DEVICE WAS USED PRE-TREATMENT. THE BLOOD INLET WAS FOUND FRACTURED WHEN CHECKING BEFORE SET-UP, THE PACKAGE WAS IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628019 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200907C 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR