BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CXD II

    MDR report key: 1954486 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00346
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS ARE INSTRUCTED TO DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THIS INCIDENT IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS NURSE REPORT FROM THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENT. IT WAS NOT REPORTED WHETHER THE PERITONITIS RESOLVED. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PERITONITIS WITH REGARDS TO DIANEAL PD4 AMBUFLEX THERAPY. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CXD II SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DIANEAL PD4 AMBUFLEX