BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3900620 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20721
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14B15024 AND H14C13019 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN AND CEFAZOLIN ORALLY (DOSE AND FREQUENCY UNKNOWN) FOR THE PERITONITIS. THE PATIENT WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL AND REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377933 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R HOMECHOICE, MINICAP, FLEXICAP| EXTENSION SET, DIANEAL UNKNOWN