BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 12982670 · Received December 13, 2021

    Report

    Report Number
    9681834-2021-00235
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 13, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781758
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ENTIRE ACTUAL SAMPLE DID NOT FIND ANY ANOMALY INCLUDING A BREAKAGE. EACH CONNECTION PART OF THE SAMPLING LINE OF ACTUAL SAMPLE WAS CONFIRMED. IT WAS FOUND THAT THE LOCK ADAPTER ON THE RED COCK SIDE OF SAMPLING SYSTEM WAS RUN IDLE. MAGNIFYING INSPECTION OF THE LOCK ADAPTER ON THE SAMPLING SYSTEM SIDE OF ACTUAL SAMPLE FOUND THAT THE SCREW THREAD HAD BEEN DEFORMED. MAGNIFYING INSPECTION OF THE FEMALE CONNECTOR CONNECTED TO THE RED COCK SIDE OF SAMPLING SYSTEM FOUND THAT THE FLANGE HAD BEEN DEFORMED. 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 SINCE THE SCREW THREAD OF LOCK ADAPTER AND THE FLANGE OF FEMALE CONNECTOR WERE DEFORMED, THE LOCK ADAPTER WAS RUN IDLE AND COULD NOT BE FIXED. AS A POSSIBLE CAUSE OF THE DEFORMATION FOUND ON THE ACTUAL SAMPLE, FROM PAST EXPERIENCE, IT WAS INFERRED THAT THE SCREW THREAD AND FLANGE WERE CRUSHED DUE TO EXCESSIVE TIGHTENING OF THE LOCK ADAPTER. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY WHEN THE DEFORMATION OCCURRED FROM THE STATE OF ACTUAL SAMPLE. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION TO H4. THE INCORRECT DEVICE MANUFACTURE DATE WAS INITIALLY REPORTED. THEREFORE, THE CORRECT DATE HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL- REQUESTED, NOT PROVIDED. OCCUPATION- REQUESTED, NOT PROVIDED. PMA/510(K)- K130280. THE ACTUAL DEVICE HAS NOT 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. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. THE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889485 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200904 04987350781758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown