BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2180409 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09801
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H11E31092, H11D06055, AND H11C22013 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE NURSE REPORTED THAT ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THE NURSE STATED THAT SHE DID NOT KNOW THE CAUSE OF THE PERITONITIS. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. ACTION TAKEN WITH EXTRANEAL VIAFLEX WAS NOT REPORTED. THE NURSE STATED THAT THE PERITONITIS WAS UNRELATED TO EXTRANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other HOMECHOICE| EXTRANEAL VIAFLEX