BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3013093 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06707
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT OCCURRENCE DATE OF THIS EVENT IS UNKNOWN BUT THE PERITONITIS WAS REPORTED TO HAVE INITIALLY OCCURRED IN (B)(6) 2012. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER: H12H30014. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY CRAMPING, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PERITONITIS WAS REPORTED TO BE RECURRING. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS. PD THERAPY WAS ONGOING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 1 OF 3 FOR THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115017 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

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