BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3023284 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07411
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBER(S), H12H17094 AND H12I04033, 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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE OCCURRENCE DATE FOR THE PERITONITIS EVENT IS UNKNOWN. (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 4 FOR THIS PERITONITIS EVENT. THIS IS A REPORT OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE DURING HOSPITALIZATION FOR AN UNRELATED ISSUE, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE TREATMENT FOR THE PERITONITIS INCLUDED UNSPECIFIED IV ANTIBIOTICS. THE PATIENT'S PD CATHETER WAS REMOVED, PD THERAPY WAS DISCONTINUED, AND HEMODIALYSIS WAS STARTED. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127040 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD4 AMBUFLEX