BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3071458 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10022
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12J13025 AND H12L21024 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). THE PATIENT EXPERIENCED PERITONITIS, AND THEY WERE ADMITTED INTO THE HOSPITAL ON THE SAME DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT DURING HOSPITALIZATION INCLUDED VANCOMYCIN IV(DOSE UNKNOWN) AND CEFTAZIDIME- IV(DOSE UNKNOWN). THE PATIENT WAS PRESCRIBED CEFAZOLIN IP (DOSE AND FREQUENCY WAS UNKNOWN) AND VANCOMYCIN IP X1 (DOSE UNKNOWN) FOR TREATMENT AT HOME. THE PATIENT WAS RECOVERING FOR THIS EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171797 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R LOW CALCIUM YELLOW 1.5% SINGLEBAG