BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 10834996 · Received November 13, 2020

    Report

    Report Number
    9681834-2020-00231
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 13, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- CLINICAL ENGINEER. PMA/510(K)- K130280. DEVICE MANUFACTURER DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE CONFIRMED NO DEFORMATION, OR NO OTHER VISIBLE ANOMALY IN THE OUTER SURFACE. MAGNIFYING INSPECTION INSIDE THE ACTUAL SAMPLE FOUND THAT THE CONNECTION PART HAD BEEN SNAPPED OFF IN THE MIDDLE. IT WAS CONFIRMED THAT NO FOREIGN SUBSTANCE THAT COULD IMPAIR THE STRENGTH OF THIS PART WAS MIXED IN THE MATERIAL. ELECTRON MICROSCOPIC INSPECTION REVEALED THAT THE BROKEN SURFACE WAS SMOOTH AND PARTIALLY ROUGH. FROM THIS, IT IS LIKELY THAT A CRACK SPREAD IN THE CONNECTION PART FROM THE SMOOTH-SURFACE SIDE TOWARD THE ROUGH-SURFACE SIDE. IT WAS LIKELY THAT THE CRACK DEVELOPED SWIFTLY IN THE SMOOTH-SURFACE AREA, WHILE IN THE ROUGH-SURFACE AREA, IT DEVELOPED SLOWLY. REPRODUCTIVE TESTING WAS PERFORMED, AND A SHOCK LOAD WAS APPLIED TO AN OXYGENATOR LUER-THERMISTOR FROM THE RETENTION SAMPLE (TEST SAMPLE). AS A RESULT, THE CONNECTION PART OF THE TEST SAMPLE WAS BROKEN, AND THE BROKEN STATE WAS CONFIRMED TO BE SIMILAR TO THAT OBSERVED IN THE ACTUAL SAMPLE. NO DEFORMITY WAS OBSERVED FROM THE OUTSIDE. ELECTRON MICROSCOPIC INSPECTION OF THE TEST SAMPLE REVEALED THAT NEAR THE AREA WHERE THE SHOCK LOAD WAS APPLIED, THE BROKEN SURFACE WAS SMOOTH, AND IN THE AREA OPPOSITE TO THAT, THE BROKEN SURFACE WAS FOUND ROUGH. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. 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 THE ACTUAL SAMPLE WAS SUBJECTED TO A SHOCK LOAD, WHICH RESULTED IN THE BREAKAGE IN THE CONNECTION PART. FROM THE STATE OF THE ACTUAL SAMPLE, HOWEVER, IT WAS DIFFICULT TO DETERMINE THE EXACT TIMING WHEN THE SHOCK LOAD WAS EXERTED ON THE ACTUAL SAMPLE. 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 THAT UPON OPENING THE CAPIOX DEVICE OXYGENATOR PACKAGE PRE-TREATMENT, THEY FOUND THAT A LUER THERMISTOR HAD DISLODGED. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299809 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1