BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3972733 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24987
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14E09053 AND H14D18073. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OTHER INDICATIONS. ON AN UNREPORTED DATE, DURING HOSPITALIZATION, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS TREATED FOR THE PERITONITIS WITH FORTAZ, INTRAPERITONEALLY (IP) (DOSE AND FREQUENCY NOT REPORTED). IT WAS NOT REPORTED WHETHER THE PERITONITIS EVENT PROLONGED THE PATIENT¿S HOSPITALIZATION. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450748 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MINICAP, FLEXICAP| DIANEAL SOLUTION, MINICAP TRANSFER SET