BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3203674 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17093
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON H13C20064 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2. IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE WAS UNKNOWN. THE PATIENT WAS TREATED WITH AN UNKNOWN ANTIBIOTIC. SEVENTY ONE DAYS LATER, THE PATIENT WAS HOSPITALIZED TO HAVE THE PD CATHETER REMOVED. THE PATIENT WILL NOT CONTINUE ON PD THERAPY BUT HAS BEEN PLACED ON HEMODIALYSIS. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON AN UNKNOWN DATE AFTER THE PD CATHETER WAS DISCONTINUED. THE PDRN DOES NOT KNOW IF THE PATIENT HAS RECOVERED FROM THE RECURRENT EPISODES OF PERITONITIS DUE TO NO LONGER A PATIENT AT THE PD CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304510 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R DIANEAL PD4 AMBUFLEX