BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2971813 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04298
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE ? MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER: H12J26043. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED, AS THERE WAS NO SAMPLE AVAILABLE. THE CAUSE OF THE PERITONITIS COULD NOT BE DETERMINED, AS NO DEVICE MALFUNCTION NOR USE ERROR WAS IDENTIFIED DURING THE REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS FOR THIS EVENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT INCLUDED VANCOMYCIN AND GENTAMICIN. THE PATIENT RECOVERED FROM THE PERITONITIS. PD THERAPY WAS ONGOING. THE EVENT WAS NOT RELATED TO HOMECHOICE MACHINE, DISPOSABLE PARTS, OR ANY BAXTER SOLUTIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76670 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE ? MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R DIANEAL 2.5% LOW CAL AMBUFLEX