BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2961273 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03747
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12K05011, H12J14015 AND H12F22072 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AS (B)(4) AND THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED PERITONITIS COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING, ALTHOUGH THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ABOUT THREE WEEKS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND CONTINUED TO TAKE ANTIBIOTICS WHILE AT HOME. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64810 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX