BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2964362 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03993
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS 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). ADDITIONAL INFORMATION:A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER H12J20012 AND H12K11035. THERE WERE NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME PATIENT AS (B)(4). THIS IS A REPORT OF PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). THE PATIENT HAD EXPERIENCED A MRSA INFECTION TWICE WITHIN A MONTH. A TREATMENT OF VANCOMYCIN IV (DOSAGE UNKNOWN) FOR THE MRSA INFECTION. DURING THIS TIME THE PATIENT WAS HOSPITALIZED FOR FUNGAL PERITONITIS, HOWEVER TREATMENT FOR THE FUNGAL PERITONITIS WAS NOT REPORTED. ABOUT A WEEK LATER, THEY WERE REMOVED FROM PERITONEAL DIALYSIS AND MOVED ONTO HEMODIALYSIS. FOUR DAYS LATER THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS REPORTED TO HAVE BEEN RECOVERING. THE PATIENT WAS RETRAINED ON PROPER PD TECHNIQUE (DATE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68769 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG