BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013628 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03010
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE FOR THE REPORT OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10H21023, H10I10024, H10J26052), WITH NO DEFECTS NOTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY NOT REPORTED) AND EXTRANEAL VIAFLEX (DOSE, FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE NURSE CONTACTED BAXTER VIA DIRECT ACCESS AND REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON AN UNREPORTED DATE. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN AND THE PATIENT'S PD CATHETER WAS REMOVED. THE OUTCOME FOR THE PERITONITIS WAS NOT REPORTED. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE PERITONITIS WITH REGARDS TO DIANEAL AND EXTRANEAL THERAPIES.

    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 62 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE