BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3023069 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07394
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS THE SAME PATIENT AS (B)(4). THE REPORTED CONDITION WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE NO SAMPLE WAS RETURNED TO BAXTER, THE REVIEW OF MANUFACTURING RECORDS FOR POTENTIALLY ASSOCIATED LOTS H12L07023 AND H12L10019 REVEALED NO ISSUES OR DEVIATIONS FROM STANDARD PROCEDURE, AND THE USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER DEVICE MALFUNCTIONS THAT MIGHT HAVE CAUSED THE REPORTED ISSUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS HOSPITALIZED FOR 3 DAYS FOR PERITONITIS MANIFESTED BY LOW BLOOD PRESSURE AND FALL COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY USING BAXTER DISPOSABLE PRODUCTS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN, INTRAPERITONEALLY (IP), FOR THE PERITONITIS EVENT (DOSAGE AND FREQUENCY WERE UNKNOWN). APD THERAPY WAS ONGOING DURING THE HOSPITALIZATION AND PERITONITIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS FEELING BETTER AND RECOVERING FROM THIS EVENT OF PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126795 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R DIANEAL PD2 AMBUFLEX 1.5% AND 2.5%| HOMECHOICE