BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4132752 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-34014
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE SAMPLE WAS NOT RETURNED, A DEVICE EVALUATION CANNOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER H14A29019 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY SEVERE ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS EVENT WAS UNKNOWN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR PERITONITIS. ELEVEN DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, ANTIBIOTIC THERAPY WAS ONGOING WITH ORAL LEVOFLOXACIN 500 MG, ONCE EVERY OTHER DAY. PD THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611301 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14A29019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R TRANSFER SET, TITANIUM ADAPTER, MINICAP| DIANEAL AMBUFLEX| HOMECHOICE