BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3943979 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23231
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: DATE OF EVENT - ON AN UNREPORTED DATE IN (B)(6) 2014, THE PT EXPERIENCED AND WAS DIAGNOSED WITH PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14D14098 AND H14C11039 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE SAMPLE WAS NOT RETURNED, A COMPLETE DEVICE ANALYSIS CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE, FREQUENCY NOT REPORTED) IP (INTRAPERITONEALLY) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND PERITONITIS WAS RESOLVING, AND THE PATIENT WAS RECOVERING. THE DIANEAL THERAPIES WERE ONGOING. IT WAS REPORTED THAT ON AN UNSPECIFIED FUTURE DATE, THE PT WILL BE HAVING A NEW PD CATHETER PLACED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422362 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MINICAP| DIANEAL PD4 2.5% AND 4.25% AMBUFLEX