BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3191140 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16460
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 4, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H13A29085 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.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 5 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 WAS HOSPITALIZED FOR THE EVENT OF PERITONITIS. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291106 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R DIANEAL PD4 AMBUFLEX