BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 12090871 · Received June 30, 2021

    Report

    Report Number
    9681834-2021-00109
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 30, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. NAME: (B)(6). PMA/510(K): K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WITH UNAIDED EYE REVEALED THAT THE UPPER PART OF THE OXYGENATOR WAS FOUND FRACTURED AT THE MATING PART WITH THE RESERVOIR. THERE WAS NO DAMAGE, DEFORMATION, OR OTHER EXTERNAL ANOMALY OBSERVED IN OTHER PARTS. THE FRACTURE SURFACE WAS INSPECTED WITH A MAGNIFIER AND FOUND SMOOTH OVERALL. STREAKY PATTERN WAS FOUND EXTENDING FROM THE FRONT (BLOOD OUTLET PORT SIDE) OF THE OXYGENATOR. FROM THIS, IT WAS CONCEIVABLE THAT A MOMENTANEOUS LOAD WAS APPLIED TO THE ACTUAL SAMPLE CAUSING THE FRACTURE TO HAVE EXTENDED FROM THE FRONT SIDE OF THE OXYGENATOR ALONG 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 SATES: 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 WAS LIKELY THAT THE ACTUAL SAMPLE WAS FRACTURED DUE TO HAVING BEEN SUBJECTED TO IMPACT LOAD. AS FOR THE TIMING OF THE IMPACT, SINCE NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS, IT WAS THOUGHT THAT THE IMPACT LOAD WAS UNEXPECTEDLY APPLIED DURING TRANSPORTATION OR STORAGE; HOWEVER, THE DETAILED TIMING COULD NOT BE IDENTIFIED FROM THE CONDITION OF THE ACTUAL SAMPLE. 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 (B)(4) 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 SUPPORT ARM OF OXYGENATOR WAS BROKEN WHEN THEY OPENED THE PACKAGE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992050 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200521C 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1