BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3950981 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23698
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4). A BATCH REVIEW WILL BE PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H14D27017, H14C30039, AND H14B16030. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT H14D27017, H14C30039 AND H14B16030 WAS PERFORMED 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. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAPIME 1GM DAILY INTRAPERITONEALLY FOR THE PERITONITIS EVENT. THERAPY WITH CEFAPIME WAS COMPLETED ON THE DAY THE PATIENT WAS RECOVERED FROM THE PERITONITIS. SIX DAYS AFTER THE START OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT EIGHT DAYS AFTER HOSPITAL DISCHARGE. DIANEAL AND EXTRANEAL THERAPIES WERE ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427862 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R HOMECHOICE, MINICAP, EXTENSION SET, EXTRANEAL| DIANEAL 2.5% LOW CALCIUM PD4