BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT GAMMA DIALYZER (CT 190G)

    MDR report key: 742677 · Received July 18, 2006

    Report

    Report Number
    1423500-2006-00830
    Event Type
    Malfunction
    Date Received
    July 18, 2006
    Date of Event
    February 13, 2006
    Report Date
    June 19, 2006
    Manufacturer
    NIPRO CORPORATION
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE LOT NUMBER MAY BE D05A31X AND NOT 005A31X AS REPORTED BY THE FDA - NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. SPECIFICALLY, ALICE MEHNER - BAXTER COMPLIANCE ASSOCIATE CALLED SHIRLEY ZEIGLER AT THE FDA ON 06/20/06 TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. DURING THIS DISCUSSION MS. ZIEGLER ADVISED THAT WE DOCUMENT THE FOLLOWING IN THE COMPLAINT: PER MS. ZEIGLES, FDA, THIS CUSTOMER REQUESTED THAT THEIR IDENTITY NOT BE RELEASED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION FROM THE FDA REPORT: VOLUNTARY 08-MAR-2006: BLOOD LEAK ALARM - VISIBLE BLOOD IN DIALYSATE AND EXTRA CORPOREAL CIRCUIT. THE REPORTER'S OCCUPATIONS IS LISTED AS NURSE. FOR THE FIELD REPROCESSED AND REUSED IT IS INDICATED AS NO. THIS COMPLAINT WAS RECEIVED AT THE FDA ON 03-08-06 AND THE EVENT DATE WAS APPROX A MONTH EARLIER. THE LETTER WAS RECEIVED BY BAXTER ON JUNE 19, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT GAMMA DIALYZER (CT 190G) HOLLOW FIBER DIALYZER FJI NIPRO CORPORATION 5M1546 005A31X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN