BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3870942 · Received June 12, 2014

    Report

    Report Number
    1416980-2014-18816
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H14A25033 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. THE DEVICE WAS NOT RETURNED, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. IN THE SAME MONTH AS THE ONSET, THE PT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME INTRAPERITONEALLY (DOSE AND FREQUENCY UNSPECIFIED). THREE DAYS AFTER HOSPITALIZATION, THE PT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERED FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347083 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R EXTENSION SET| MINICAP| MINICAP TRANSFER SET| HOMECHOICE| DIANEAL PD4