BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 6773960 · Received August 8, 2017

    Report

    Report Number
    9681834-2017-00170
    Event Type
    Injury
    Date Received
    August 8, 2017
    Date of Event
    July 13, 2017
    Report Date
    August 8, 2017
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. FOR THIS REASON CODE 20 WAS USED IN THE CONCLUSIONS SECTION OF H6. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS. 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 PRESSURE INCREASE IN THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PRESSURE INCREASED IN THE CAPIOX DEVICE TO 470 MMHG; AFTERWARDS THE PRESSURE WAS 120 MMHG; THE FLOW WAS 4.6 L/MIN.; THE OXYGENATOR WAS REPLACED WITH OTHER TERUMO PRODUCT WITHOUT ANY COMPLICATIONS; THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE; THERE WAS NO BLOOD LOST; TREATMENT WAS EXECUTED AS PLANNED; THE PATIENT WAS TREATED AS INTENDED; THE PATIENT RECOVERED FROM THE REPORTED SERIOUS INJURY; AND THE USER REPORTED THIS EVENT TO (B)(6) AS FOLLOWS: FOR AN AORTA VALVE INSPECTION THE PATIENT WAS CONNECTED TO THE HEART LUNG MACHINE (12:14 H START TIME). DURING THE PERFUSION (12:50) THE PRESSURE BEFORE OXYGENATOR STARTED TO INCREASE WITHOUT NOTICEABLE REASON, THE SYSTEM WAS EXCHANGED AT 12:59. BEFORE PERFUSION BEGAN THE ACT WAS 526S. AT OXYGENATOR EXCHANGE THE ACT WAS 606S. THE EXCHANGE LED TO CIRCULATORY ARREST OF 57 SECONDS, WITH A BODY TEMPERATURE OF 32°C. THE EXCHANGE HAPPENED BY ROUTINE AND TROUBLE-FREE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NUMBER 1 TO PROVIDE THE ACTUAL DEVICE EVALUATION RESULTS AS WELL AS THE LOT NUMBER, EXPIRATION DATE AND MANUFACTURING DATE. VISUAL INSPECTION FOUND NO OBVIOUS ANOMALIES IN THE APPEARANCE OF THE DEVICE. THE ACTUAL DEVICE WAS RINSED, DRIED AND SUBJECTED TO ANOTHER VISUAL INSPECTION. IT WAS CONFIRMED NOT TO HAVE ANY ANOMALIES. THE ACTUAL DEVICE WAS BUILT INTO A CIRCUIT. BOVINE BLOOD @HCT35% AND TEMP. 37°C WAS CIRCULATED IN THE CIRCUIT, WHILE THE PRESSURE DROP WAS DETERMINED AT EACH FLOW RATE. THE OBTAINED VALUES WERE CONFIRMED TO MEET MANUFACTURING SPECIFICATIONS. BOVINE BLOOD WAS KEPT CIRCULATED IN THE ACTUAL DEVICE FOR 6 HOURS. NO OBSTRUCTION OCCURRED. WHEN THE CIRCULATION WAS CEASED, THE ACTUAL DEVICE WAS FLUSHED WITH WATER. NO CLOT WAS FOUND INSIDE THE ACTUAL DEVICE. THE PERFUSION RECORD WAS REVIEWED. AT 12:14 THE CIRCULATION WAS INITIATED. AT 12:50 THE INLET PRESSURE INCREASED. AT 12:59, THE ACTUAL OXYGENATOR WAS CHANGED OUT. AT THE INITIATION OF THE CIRCULATION NO INCREASE IN THE PRESSURE WAS NOTED. FROM THIS, IT IS ASSUMABLE CLOTS FORMED DURING THE CIRCULATION AND THE OXYGENATOR WAS OBSTRUCTED, RESULTING IN THE REPORTED HIGH PRESSURE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE FOUND ONE OTHER REPORT OF THIS NATURE FROM THE SAME USER FACILITY WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. SEE MDR 9681834-2017-00173. THERE IS NO EVIDENCE THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULT VERIFIED THE ACTUAL DEVICE WAS THE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN EVENT IN THE INSTRUCTIONS-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: DO NOT REDUCE HEPARIN DURING CIRCULATION. OTHERWISE, BLOOD CLOTTING MIGHT OCCUR. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556237 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 141031 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other