BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT-190G CELLULOSE TRIACETATE

    MDR report key: 985514 · Received January 25, 2008

    Report

    Report Number
    1423500-2008-00038
    Event Type
    Injury
    Date Received
    January 25, 2008
    Date of Event
    December 27, 2007
    Report Date
    December 27, 2007
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    MSF
    PMA / PMN Number
    KK890315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS RECEIVED, BUT NOT EVALUATED YET. HOWEVER, THE MANUFACTURING FACILITY, (NIPRO CORPORATION) HAS BEEN MADE AWARE OF THIS REPORT. A BATCH REVIEW OF THE REPORTED LOT, REVEALED NO ABNORMALITIES. FURTHERMORE, THE MANUFACTURER IS CURRENTLY CONDUCTING BIOLOGICAL TESTS USING A SAMPLE OF THE CONCERNED LOT. THE RESULTS WILL BE PROVIDED TO BAXTER UPON COMPLETION. BAXTER IS MONITORING ISSUES LIKE THIS. AN INVESTIGATION IS STILL PENDING. SHOULD SIGNIFICANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT 30 SECONDS INTO HEMODIALYSIS TREATMENT, A PATIENT HAD NAUSEA AND SEVERE VOMITING. THE BLOOD FLOW RATE WAS REDUCED AND 150ML OF NORMAL SALINE WAS GIVEN TO THE PATIENT. REPORTEDLY, AFTER THE INTERVENTION, THE PATIENT RECOVERED AND WAS ABLE TO COMPLETE THE PRESCRIBED TREATMENT WITHOUT FURTHER MEDICAL INTERVENTIONS. THE CT 190G DIALYZER WAS PREPROCESSED. THE REUSE NUMBER IS 4. THE DIALYZER WAS PLACED ONTO THE GAMBRO PHOENIX MACHINE AND WAS PRIMED WITH 500 ML OF NORMAL SALINE. THE PATIENT HAS USED THE CT 190G DIALYZER FOR MANY YEARS. THE PATIENT HAS AN ARTERY VENOUS (AV) FISTULA ACCESS. THE FACILITY HAS A STANDARD RECIRCULATION TIME OF 10 MINUTES BEFORE PATIENTS ARE PUT ON THE MACHINE. THE FACILITY DID NOT SPECIFICALLY KNOW HOW LONG THE RECIRCULATION WAS PRIOR TO THIS PATIENT BEING PUT ON THE MACHINE. THE PATIENT WAS GIVEN A BOLUS OF BAXTER HEPARIN AT THE START OF TREATMENT OF 1500 UNITS AND 1000 UNITS HOURLY. THE PT'S PRE-WEIGHT, DRY WEIGHT, AND POST WEIGHT WAS FLUCTUATED. THE TARGET LOSS WAS 5.O KG. THE PATIENT NORMALLY TOLERATES THE TREATMENTS. A BLOOD SAMPLE WAS TAKEN FROM THE PATIENT IN 2007. THE RESULTS WERE REQUESTED BUT HAVE NOT BEEN RECEIVED. A SAMPLE WAS TAKEN FROM THE MACHINE AND IT WAS CULTURED. THE TEST RESULT FROM THE MACHINE CAME BACK AS NORMAL. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT-190G CELLULOSE TRIACETATE 78MSF MSF NIPRO CORPORATION USD 07E10EX

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention GAMBRO PHOENIX HEMODIALYSIS INSTRUMENT| LOT NUMBERS 107066 AND 097081| BAXTER HEPARIN SODIUM INJECTION 30 ML VIALS