BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 9552429 · Received January 6, 2020

    Report

    Report Number
    9681834-2019-00231
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 6, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K040210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION TO SECTION D4. EXPIRATION DATE. THE EXPIRATION DATE OF 31-DEC-2021 WAS INADVERTENTLY INITIALLY SUBMITTED. THE CORRECT DATE IS 31-OCT-2021; THEREFORE SECTION D4 HAS BEEN UPDATED TO REFLECT THE CORRECT DATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL LOT NUMBER WAS CONFIRMED TO BE 181112; THEREFORE, SECTION D4 AND H4 HAVE BEEN UPDATED. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLING LINE CONNECTED TO THE BLOOD OUTLET PORT REVEALED THAT IT HAD BEEN PERFORATED ON APPROXIMATELY 5CM - 7CM FROM THE PORT. THE LENGTH OF THE SAMPLING LINE BETWEEN THE BLOOD OUTLET PORT AND THE FEMALE LUER CONNECTOR WAS MEASURED AND CONFIRMED THERE WAS NO ANOMALY. THE OXYGENATOR HAD DISLODGED FROM THE SUPPORT ARM, AND THE ELBOW CONNECTOR, WHICH HAD BEEN CONNECTED TO THE VENOUS BLOOD INLET PORT ON THE RESERVOIR, HAD BEEN BROKEN OFF. HOWEVER, IT WAS ASSUMABLE THAT THESE DEFECTS HAD BEEN CAUSED DURING THE TRANSPORTATION BACK TO ASHITAKA SINCE THEY WERE NOT POINTED OUT IN THE COMPLAINT DESCRIPTION. THE STATE OF THE PERFORATION SURFACE WAS INSPECTED WITH CCD AND SEM. THE SURFACE WAS SMOOTH, AND STREAK LINES WERE SEEN PARALLEL IN THE TUBE'S LENGTHWISE DIRECTION. REPRODUCTIVE TESTING WAS PERFORMED ON FACTORY-RETAINED SAMPLING LINE SAMPLES WERE DAMAGED BY THE FOLLOWING METHOD AND THE STATE OF THE DAMAGE SURFACE WAS INSPECTED WITH SEM. WHEN THE TEST SAMPLES WERE CUT FROM ONE DIRECTION WITH A BLADE (SAMPLE 1: CUT WITH A BLADE IN THE TUBE'S LENGTHWISE DIRECTION; SAMPLE 2: CUT WITH A BLADE IN THE TUBE'S CROSS-SECTIONAL DIRECTION), THE DAMAGED SURFACE WAS SMOOTH AND SIMILAR TO THAT OF THE ACTUAL SAMPLE. WHEN THE TEST SAMPLE WAS CUT WITH SCISSORS, THE CUT SURFACE WAS FOUND DIFFERENT FROM 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. DO NOT USE AN OXYGENATOR THAT LEAKS. 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 SAMPLING LINE SAMPLE WAS EXPOSED TO A BLADE AND A SECTION OF THE TUBE GOT PERFORATED. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    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. REVIEW OF DEVICE HISTORY RECORDS AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PERFUSIONIST FOUND BEFORE PRIMING, A BROKEN LINE IN INLET TO CAPIOX OXYGENATOR RESERVOIR (PERFORATED LINE). THE EVENT OCCURRED PRE-TREATMENT, THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17092 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 181112

    Patients

    Seq Age Sex Outcome Treatment
    1