BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 5966310 · Received September 21, 2016

    Report

    Report Number
    9681834-2016-00229
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    July 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - UDI NUMBER FOR THIS PRODUCT CODE IS NOT REQUIRED TO BE REGISTERED. THE ACTUAL DEVICE WAS DISCARDED BY THE INVOLVED FACILITY. THEREFORE THE INVESTIGATION IS BASED ON THE USER FACILITY INFORMATION AND EVALUATION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT NUMBER. VISUAL INSPECTION REVEALED NO DEFECTS. VISUAL INSPECTION OF THE THERMISTOR PROBE REVEALED NO DEFECTS. THE RETENTION SAMPLE WAS BUILT INTO A CIRCUIT WITH TUBES, WITH ONE THERMISTOR PROBE ATTACHED TO UPSTREAM AND ANOTHER TO DOWNSTREAM OF THE OXYGENATOR. BOVINE BLOOD WAS CIRCULATED IN THE CIRCUIT AND THE TEMPERATURE WAS DETERMINED AT THREE POINTS AND CONFIRMED THERE WAS NO DIFFERENCE IN THE OBTAINED VALUES. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT/LOT # COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE RESULTS OF THE INVESTIGATION VERIFIED THAT THE RETENTION SAMPLE WAS NORMAL PRODUCT. BASED ON THE INFORMATION PROVIDED BY THE INVOLVED CUSTOMER, THEIR USE OF A BEAR HUGGER MAY HAVE AFFECTED THE BLOOD TEMPERATURE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : ACTUAL DEVICE DISCARDED BY FACILITY

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A BAD CONNECTION DURING THE USE OF THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: WE HAVE NOTICED, OUR ARTERIAL TEMPERATURES ARE UNDER-READING AND LOWER VENOUS TEMPERATURE WHILE REWARMING THE PATIENT; IT WAS REPORTED THEY TRIED CHANGING THE CABLE AND CLEANING THE CONTACT POINTS WITH NO LUCK; THIS HAS BEEN NOTICEABLE USING DIFFERENT HEATER COOLERS IN DIFFERENT THEATRES AT THE PUBLIC HOSPITAL; IT WAS REPORTED THAT THE CUSTOMER USES A BEAR HUGGER PRE SURGERY TO WARM THE PATIENT; IF THE BEAR HUGGER IS NOT TURNED OFF AT THE RIGHT TIME BEFORE SURGERY THE PATIENT TEMPERATURE ON ENTERING SURGERY SEEMS HIGHER THAN NORMAL AND IS BEING SEEN THROUGH THE THERMISTOR WIRE READING ON THE HL20 HEART LUNG MACHINE; IT WAS REPORTED THAT THE PERFUSIONIST IS NOT SEEING THIS AS A PATIENT SAFETY RISK; THEY MEASURE THE CORE PATIENT TEMPERATURE USING A NASAL CANNULA AND THEN ALSO HAVE THE TEMPERATURE THROUGH THE THERMISTOR WIRE; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS NOT HARMED. THE USER FACILITY REPORTED A SIMILAR COMPLAINT RELATED TO ANOTHER DEVICE FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION; SEE MDR 9681834-2016-00230.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NUMBER 1 TO CORRECT THE BRAND NAME FROM CAPIOX FX OGYGENATOR TO CAPIOX RX OGYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620040 CAPIOX RX OXYGENATOR OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA NA 151212

    Patients

    Seq Age Sex Outcome Treatment
    1