BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3212100 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17750
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12K13056 AND H13A18070 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. 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 4 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. DIANEAL THERAPY WAS ONGOING. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAM IP Q 3 DAYS FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310173 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R DIANEAL PD2 AMBUFLEX AND DIANEAL PD2 ULTRABAG| HOMECHOICE| MINICAP, MINICAP TRANSFER SET, FLEXICAP,