BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2970351 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04274
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12K07108, H12J12043 AND H12I10105 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT EXPERIENCED A BAD COUGH. THE PATIENT WAS HOSPITALIZED FOR THE COUGH AND TREATED WITH UNSPECIFIED ANTIBIOTICS AND COUGH SYRUP. WHILE HOSPITALIZED, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS INTRA-PERITONEALLY FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENTS OF PERITONITIS AND BAD COUGH. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73616 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R HOMECHOICE, DIANEAL PD4 AMBUFLEX