BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3142825 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14097
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBERS H13A10069 AND H13B12014 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 FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    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 EXPERIENCED PERITONITIS AND WAS HOSPITALIZED. THE CONSUMER THOUGHT THAT THE PERITONITIS WAS RELATED TO THE COLONOSCOPY AND THE NURSE STATED THAT IT COULD HAVE BEEN THE TECHNIQUE (SPECIFICS NOT REPORTED). TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT WAS PUT ON BACKUP HEMODIALYSIS. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244603 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R DIANEAL PD4 AMBUFLEX