BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3972722 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-24981
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14D06037 AND H14E17080. THERE WERE NO ISSUES DETECTED DURING THE MANUFACTURING PROCESSES. AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH ANCEF (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THIRTEEN DAYS AFTER RECEIPT OF THIS REPORT, THE PATIENT WAS RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450565 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention MINICAP TRANSFER SET, FLEXICAP| DIANEAL PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTIONS| HOMECHOICE, MINICAP