BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HEMOCONCENTRATOR

    MDR report key: 5476003 · Received March 3, 2016

    Report

    Report Number
    9681834-2016-00035
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 8, 2016
    Report Date
    March 3, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    KDI
    PMA / PMN Number
    K973516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION FOUND NO OBVIOUS ANOMALIES IN THE APPEARANCE. THE ACTUAL SAMPLE WAS RINSED, DRIED AND SUBJECTED TO ANOTHER VISUAL INSPECTION. NO ANOMALIES WERE REVEALED. BOVINE BLOOD WAS CIRCULATED IN THE BLOOD PATHWAY. NO ANOMALIES OR CLOGGING WAS OBSERVED. 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. A SEARCH OF THE COMPLAINT FILE FOUND NO REPORT OF THIS NATURE WITH THE INVOLVED PRODUCT/LOT# COMBINATION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AND THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTION FOR USE (IFU) WITH THE STATEMENT SUCH AS THE FOLLOWING: (1) "THE CAPIOX HEMOCONENTRATOR IS DESIGNED TO OPERATE AT FLOW RATES WITHIN THE RANGE OF 100 TO 500ML/MIN DURING ULTRAFILTRATION. DO NOT USE BLOOD FLOW RATES OUTSIDE THIS RANGE. LESS THAN 100 ML/MIN BLOOD FLOW MAY CAUSE BLOOD COAGULATION IN THE DEVICE." (2) "STOP USING THE HEMOCONCENTRATOR IF BLOOD LEAKAGE, CLOTTING OR ANY OTHER PROBLEM IS OBSERVED. REPLACE IT WITH A NEW ONE." AND (3) "DO NOT STOP BLOOD FLOW DURING EXTRACORPOREAL CIRCULATION AS IT MAY CAUSE CLOTTING IN THE SYSTEM. A BLOOD FLOW OF AT LEAST 50ML/MIN IS RECOMMENDED EVEN IF ULTRAFILTRATION IS STOPPED BY CLAMPING THE FILTRATE LINE." 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 AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A CLOG IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE HEMOCONCENTRATOR WAS CLOGGED; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS NOT HARMED.

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 FOR MFG. REPORT NO. 9681834-2016-00035 TO MAKE A CORRECTION TO THE 510(K) NUMBER INITIALLY DOCUMENTED. THE INITIAL NUMBER DOCUMENTED WAS K022115, THE CORRECT LOT NUMBER IS K973516.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 FOR MFG. REPORT NO. 9681834-2016-00035 TO MAKE A CORRECTION TO THE 510(K) NUMBER INITIALLY DOCUMENTED. THE INITIAL NUMBER DOCUMENTED WAS K022115, THE CORRECT LOT NUMBER IS K973516.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133519 CAPIOX HEMOCONCENTRATOR DIALYZER KDI TERUMO CORPORATION, ASHITAKA NA 150915

    Patients

    Seq Age Sex Outcome Treatment
    1