BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 11677159 · Received April 16, 2021

    Report

    Report Number
    9681834-2021-00067
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 16, 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 · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE PORT OF THE SAMPLING LINE WHERE THE BLUE STOPCOCK IS ATTACHED HAD BEEN FRACTURED AND DISLODGED FROM THE BASE. THE FRACTURE SURFACE OF THE PORT WAS INSPECTED UNDER A MAGNIFIER AND ELECTRON MICROSCOPE. IT WAS FOUND SMOOTH OVER THE ENTIRE SURFACE. STREAKY PATTERN STARTING FROM THE UPPER SIDE OF THE STOPCOCK WAS OBSERVED. FROM THIS, IT WAS PRESUMED THAT A MOMENTANEOUS SHOCK LOAD WAS APPLIED TO THAT AREA, RESULTED IN THE FRACTURE. REPRODUCTIVE TESTING WAS PERFORMED, AND AN EXCESSIVE SHOCK LOAD WAS APPLIED TO A PORT OF THE SAMPLING SYSTEM OF A FACTORY-RETAINED CURRENT PRODUCT SAMPLE FROM THE LATERAL SIDE. AS A RESULT, THE PORT WAS FRACTURED. THE FRACTURE SURFACE OF THE REPRODUCTIVE TEST SAMPLE WAS INSPECTED UNDER A MAGNIFIER AND ELECTRON MICROSCOPE. THE STATE OF THE FRACTURE SURFACE WAS FOUND SIMILAR TO THAT OF THE ACTUAL SAMPLE. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. 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 SHOCK LOAD WAS APPLIED TO THE UPPER SIDE OF THE STOPCOCK ON THE ACTUAL SAMPLING SYSTEM, WHICH RESULTED IN THE FRACTURE OF THE PORT. SINCE NO ANOMALY WAS NOTED IN THE MANUFACTURING-RELATED RECORDS, IT WAS CONCEIVABLE THAT THE ACTUAL SAMPLE WAS SUBJECTED TO SUCH A SHOCK LOAD UNEXPECTEDLY AT SOME POINT DURING TRANSPORTATION OR STORAGE; HOWEVER, FROM THE STATE OF THE ACTUAL SAMPLE, THE EXACT TIMING COULD NOT BE DETERMINED. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K130280. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. 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 3-WAY STOPCOCK ON SAMPLING LINE WAS FOUND FRACTURED WHEN CHECKING, 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
    576113 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200803C 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR