BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4052028 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29245
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN AUTOMATED PD SET WITH CASSETTE, WHILE (B)(4) ADDRESSES THE MINICAP REPORT AND (B)(4) ADDRESSES THE TRANSFER SET REPORT FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR A WEEK DUE TO THE REPORTED EVENT. THE TREATMENT FOR THE PERITONITIS WAS AN UNSPECIFIED ANTIBIOTIC (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE PATIENT HAD RECOVERED FROM PERITONITIS. THE PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534471 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R HOMECHOICE, MINICAP, TRANSFER SET| DIANEAL PD4 1.5%, 2.5% AND 4.25% AMBUFLEX