BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3801913 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14873
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H13I27058 AND H13E18030 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, DIARRHEA, AND ABDOMINAL CRAMPS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. THE PT WAS REPORTED TO BE RECOVERING FROM THE EVENT. TREATMENT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THIS IS REPORT 1 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281331 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MINICAP TRANSFER SET| DIANEAL PD4 2.5% ULTRABAG| MINICAP| EXTENSION SET| HOMECHOICE| CAPD DISCONNECT Y SET| DIANEAL PD4 1.5%. 2.5% AND 4.25% AMBUFLEX