BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4093908 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31614
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT (PREVIOUSLY REPORTED AS UNKNOWN OUTCOME). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED AND WAS HOSPITALIZED THE SAME DAY FOR PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON THE SAME DAY, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) INJECTION OF VANCOMYCIN 1 GM ONCE ON THE 4TH DAY AND IP INJECTION OF AMIKACIN 250 MG ONCE DAILY (DURATION NOT REPORTED). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. AT THE TIME OF THIS REPORT THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571011 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R TITANIUM ADAPTER, MINICAP| DIANEAL PD2 2.5% ULTRABAG SOLUTION