BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3973342 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25066
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14D30110 AND H14C14090 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS SAME PATIENT AS IN CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE TREATMENT WAS WITH UNSPECIFIED ANTIBIOTICS (DOSE, ROUTE AND FREQUENCY NOT REPORTED) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450871 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HOMECHOICE, MINICAP TRANSFER SET.| DIANEAL 1.5 % AND 2.5% PD4 AMBUFLEX