BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3103665 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11909
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H13A05028 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THERE WAS AN EXCEPTION NOTED FOR THE BATCH BUT DOES NOT INDICATE ANY ISSUES RELATED TO THE COMPLAINT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. DATE OF EVENT IS UNKNOWN.

    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 THERAPIES WERE ONGOING. THE PATIENT WAS HOSPITALIZED FOR VOMITING AND LOW POTASSIUM (ONSET NOT REPORTED). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT FOR ALL REPORTED EVENTS 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
    204256 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG