BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3970949 · Received July 31, 2014

    Report

    Report Number
    1416980-2014-24816
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H14D11052 AND H14E08063 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION. THE DEVICE WAS NOT RETURNED AND THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS FURTHER DESCRIBED AS COMPROMISED, UNSTABLE, (NOT FURTHER SPECIFIED) AND OLD, WHICH WAS THOUGHT TO BE CAUSES OF THE PERITONITIS, HOWEVER, NOT MEDICALLY CONFIRMED. ON THE SAME DAY AS PERITONITIS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS DURING THE HOSPITALIZATION. ON AN UNREPORTED DATE, DIANEAL THERAPY WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PATIENT WAS ON HEMODIALYSIS, THE PERITONITIS WAS NOT RESOLVED, AND THE PATIENT WAS NOT RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447963 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R HOMECHOICE| MINICAP TRANSFER SET| MINICAP| DIANEAL PD4, 2.5% AMBUFLEX