BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR

    MDR report key: 7446830 · Received April 20, 2018

    Report

    Report Number
    9681834-2018-00057
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 20, 2018
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K022115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D7: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G5: 510(K): K130493 THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND A RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. VISUAL INSPECTION OF THE RETENTION SAMPLE REVEALED NO DEFECTS. THE RETENTION SAMPLE WAS TESTED FOR ITS GAS TRANSFER PERFORMANCE IN ACCORDANCE WITH THE FACTORY'S SHIPPING INSPECTION PROTOCOL. BOVINE BLOOD WAS CIRCULATED IN THE OXYGENATOR MODULE. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE, WITH THE OBTAINED VALUES MEETING MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE REPORTED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND NO PREVIOUS REPORT WITH THE INVOLVED PRODUCT/LOT# COMBINATION. THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT/LOT# COMBINATION WAS VERIFIED TO BE THE NORMAL PRODUCT HAVING NO ISSUES WITH ITS GAS TRANSFER PERFORMANCE. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. HOWEVER, WITH NO RETURN OF THE ACTUAL SAMPLE FOR EVALUATION OR NO DETAILED INFORMATION ON THE EVENTS LEADING UP TO THE COMPLAINT, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED. 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT OXYGENATION IMMEDIATELY AFTER THE INITIATION OF THE CIRCULATION WAS POOR. IT WAS REPORTED THAT USUALLY, V/Q IS AROUND 0.3 -0.4. THIS TIME V/Q NEEDED TO BE AROUND 0.8 TO ALLOW PAO2 TO REACH HIGHER THAN 150 MMHG. IT WAS REPORTED THAT AS TIME WENT BY THE STATE BECAME BETTER. THE PROCEDURE OUTCOME IS UNKNOWN. FINAL IMPACT OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289383 CAPIOX RX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 171201

    Patients

    Seq Age Sex Outcome Treatment
    1