BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1894703 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05556
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT (H10E13091), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING FOLLOW-UP FOR AN UNRELATED ALARM, THE PATIENT INDICATED SHE HAD PERITONITIS. FOLLOW-UP INFORMATION OBTAINED IS AS FOLLOWS: THE CAUSE OF THE PERITONITIS IS UNKNOWN AND THE PATIENT HAS RECOVERED FROM THE PERITONITIS. THE PATIENT IS CURRENTLY ON HEMODIALYSIS. THE NURSE DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PERITONITIS, ONLY INDICATING THAT THE DATE OF DIAGNOSIS WAS (B)(6) 2010 AND THAT THE PATIENT'S TRANSFER SET WAS REPLACED AFTER THE DIAGNOSIS. NO FURTHER INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS ACETABULAR LOOSENING AND HIGH METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention