BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3142587 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14077
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 POTENTIALLY ASSOCIATED LOT NUMBERS H13B19027 AND H13A22064 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 FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THERAPY WAS ONGOING. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, ANTIBIOTIC TREATMENT WAS ONGOING AND THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244646 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R MINICAP, MINICAP TRANSFER SET| HOMECHOICE, DIANEAL PD4 AMBUFLEX