BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW RECIRCULATION VOLUME APDSET W/CASSETTE

    MDR report key: 1983924 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01742
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW OF POTENTIALLY ASSOCIATED LOT, H10H03013, WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THIS INCIDENT WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN, THEREFORE NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS 1 OF 3 REPORTS ASSOCIATED WITH THIS INCIDENT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL TO THE FACILITY, THE FACILITY NURSE INDICATED THE PATIENT HAD EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON (B)(6) 2010. THE PATIENT WAS TREATED WITH VANCOMYCIN AND GENTAMYCIN INTRAPERITONEAL (IP) AND INTRAVENOUS (IV) DURING HOSPITALIZATION. THE DOSES ARE UNKNOWN. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 WITH CEFTAZIDIME (IP) FOR AN UNKNOWN LENGTH OF THERAPY. THE PATIENT HAS RECOVERED FROM THE EVENT OF PERITONITIS. THE CAUSE OF THE PERITONITIS IS UNKNOWN. THE NURSE INDICATED THAT THE BAXTER DEVICES AND SOLUTIONS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APDSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Hospitalization| R LOW CA 1.5% 5L/5L DIANEAL| LOW CA 4.25% 2/3L DIANEAL| HOMECHOICE CYCLER| LOW CA 1.5% 1.5L/2L UB DIANEAL| LOW CA 2.5% 5L/5L DIANEAL