BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3930029 · Received July 11, 2014

    Report

    Report Number
    1416980-2014-22378
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14B04010, H14C08019 AND H14D02069 WAS PERFORMED 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. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE EVALUATION CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF ONSET OF THE EVENT OF PERITONITIS WAS ON AN UNREPORTED DATE IN (B)(6) 2014. AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAREGIVER (CG) REPORTED THAT THE CAUSE OF THE PERITONITIS WAS THAT THE BACTERIA ENTERED WHEN THE PATIENT WAS PERFORMING DIALYSIS THERAPY. ON AN UNREPORTED DATE, THE SAME MONTH AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TREATMENT FOR THE PERITONITIS EVENT WAS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME MONTH. THE PATIENT WAS RECOVERED FROM THE PERITONITIS. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407752 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization HOMECHOICE, MINICAP TRANSFER SET, MINICAP| DIANEAL 1.5% AND 2.5% PD4 AMBUFLEX