BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3113437 · Received May 15, 2013

    Report

    Report Number
    1416980-2013-12353
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS H12L19036 AND H13B08020. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2. THIS IS A REPORT OF PERITONITIS AND SEVERAL DIVERTICULI POPPED IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, DIANEAL AND EXTRANEAL THERAPIES WERE WITHDRAWN. THE PATIENT EXPERIENCED CLOUDY PD EFFLUENT AND PAIN AND WAS HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. DURING HOSPITALIZATION IT WAS DETERMINED THAT SEVERAL DIVERTICULI HAD POPPED (RELATED TO DIVERTICULOSIS NOT DIVERTICULITIS). THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. THE PATIENT'S CATHETER WAS REMOVED, PD THERAPY ENDED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. THE PATIENT WAS DISCHARGED HOME. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215442 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX, EXTRANEAL VIAFLEX