BEUDAMED
    FDA Adverse Event Death Summary report: N

    H/S CUVETTE 1/4X1/4-JAPAN

    MDR report key: 10282279 · Received July 16, 2020

    Report

    Report Number
    1124841-2020-00162
    Event Type
    Death
    Date Received
    July 16, 2020
    Date of Event
    June 26, 2020
    Report Date
    July 16, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DRY
    UDI-DI
    00699753270138
    PMA / PMN Number
    K915265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS VISUALLY INSPECTED FOR DAMAGE IN THE WELD AREA THAT WOULD BE INDICATIVE OF A LEAK, AND NO DAMAGE WAS NOTED. THE UNIT WAS LEFT TO SOAK IN A BLEACH SOLUTION FOR 15 MINUTES IN EFFORTS TO REMOVE AS MUCH OF THE BLOOD AS POSSIBLE WITHOUT DAMAGING THE UNIT. IT WAS THEN PRESSURIZED TO 15.0 PSI WITH AIR AND SUBMERGED IN A WATER BATH TO DETECT ANY POSSIBLE LEAKS. THE PRESSURE WAS THEN INCREASED TO APPROXIMATELY 19-20 PSI (MAXIMUM PRESSURE PER THE IFU), AND THE UNIT BEGAN TO LEAK DURING THIS TEST, IMMEDIATELY. THE PROBE WAS THEN DETACHED AND SUBMERGED IN WATER; HOWEVER, THE LEAK STOPPED UPON THE DETACHMENT. IT COULD BE SEEN THAT BUBBLES WERE FORMED ALONG THE WELD CHANNEL OF THE UNIT AFTER DETACHMENT INDICATING THAT THE LEAK WAS FROM THE CORNER OF THE WELD NEAR THE HOOP; WHERE THE DRIED BLOOD WAS FOUND UPON RECEIPT OF THE SAMPLE. A RETENTION SAMPLE FROM THE SAME PRODUCT CODE AND LOT NUMBER WAS EVALUATED USING THE SAME TEST METHOD, AND NO VISUAL DAMAGE ON THE WELD OR BARB AREA AND NO LEAK WHEN PRESSURIZED WITH AIR AND SUBMERGED IN A WATER BATH WAS OBSERVED. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), BLOOD LEAKAGE FROM THE CUVETTE WAS OBSERVED. ON (B)(6) 2020 AROUND NOON, ECMO WAS STARTED. ON (B)(6) 2020 AT 10:50AM, THE CIRCUIT WAS CHANGED AND THE REPORTED CUVETTE WAS USED. ON (B)(6) 2020 AT 9AM, AIR WAS OBSERVED IN THE UPPER PART OF THE LUNG. AFTER AIR WAS REMOVED, THERE WAS STILL AIR IN THE LUNG. THEN, BLOOD LEAKAGE FROM THE CUVETTE WAS OBSERVED, IT WAS CHANGED OUT AND NO OTHER BLOOD LEAK WAS OBSERVED. THE CUVETTE HAD BEEN USED FOR 22 HOURS ON ECMO PRIOR TO THE UNIT PRESENTING A LEAK. A SOLUTION CALLED INTRALIPOS WAS ADMINISTERED FROM THE LEFT GROIN USING V-VECMO WITH VENOUS LINE FROM THE LEFT INTERNAL CAROTID ARTERY AND ARTERIAL LINE FROM THE RIGHT GROIN. THE PATIENT HAD LEUKEMIA AND DEVELOPED PULMONARY FAILURE. MECHANICAL VENTILATOR AND ECMO WERE INITIATED. IT WAS PLANNED THAT THE PATIENT WOULD BE TRANSFERRED FOR LUNG TRANSPLANTATION. HOWEVER; BEFORE TRANSFER HAPPENED, CEREBRAL EDEMA, CEREBRAL HEMORRHAGE AND BRAIN TUMOR OCCURRED, AND EVENTUALLY THE PATIENT EXPIRED. PRODUCT WAS CHANGED OUT. BLOOD LOSS OF A FEW ML. PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE PATIENT EXPIRED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747535 H/S CUVETTE 1/4X1/4-JAPAN BLOOD GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CV-6914 WL03 00699753270138

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death CENTRIFUGAL PUMP 560 (MEDTRONIC)| CIRCUIT (SENKO MEDICAL INSTRUMENT)| ECMO (BIOCUBE4000, NIPRO)