BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3172678 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15526
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H13B21023 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. EXCEPTION SUMMARY ON THE AS400 EXCEPTION MANAGEMENT SYSTEM WAS REVIEWED FOR THIS BATCH WITH AN EXCEPTION NOTED FOR THE BATCH BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H13A21025 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. EXCEPTION SUMMARY ON THE AS400 EXCEPTION MANAGEMENT SYSTEM WAS REVIEWED FOR THIS BATCH WITH NO EXCEPTIONS WERE NOTED FOR THE BATCH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-001630351 AND CMPLNT-001630356.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT WAS BEING TREATED WITH KELFEX 500MG FOR ONE WEEK. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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). DIANEAL THERAPY WAS ONGOING. THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED REDNESS, DISCOMFORT AND PAIN BY CATHETER EXIT SITE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS BEING TREATED WITH UNSPECIFIED MEDICATIONS. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273371 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention DIANEAL PD4 AMBUFLEX