BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3950555 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23664
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14E08063 AND H14D14031 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. 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 PERITONITIS MANIFESTED BY CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. ON UNREPORTED DATE, THE PATIENT WAS TREATED WITH CIPROFLOXACIN ORALLY (DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) AND UNSPECIFIED INTRAPERITONEAL ANTIBIOTICS (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT AND ON AN UNREPORTED DATE IN THE SAME MONTH AS ONSET, THE PATIENT WAS RECOVERED FROM THE CLOUDY EFFLUENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428352 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention MINICAP, HOMECHOICE, MINICAP TRANSFER SET| DIANEAL 1.5%, 2.5%, AND 4.25% PD4 SINGLEBAG| DIANEAL1.5%, 2.5%, AND 4.25% PD4 ULTRABAG