BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3803133 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15050
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH INJECTIONS OF AMIKACIN (50MG, ROUTE AND FREQUENCY NOT REPORTED), INJECTIONS OF CIPROFLOXACIN (100MG, ROUTE AND FREQUENCY NOT REPORTED), INJECTIONS OF HEPARIN (1000 IU, FREQUENCY AND ROUTE NOT REPORTED), FORTUM (DOSE, FREQUENCY AND ROUTE NOT REPORTED) AND IMIPENEM (DOSE, FREQUENCY AND ROUTE NOT REPORTED) TO TREAT THE EVENT OF PERITONITIS. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281380 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL PD2 1.5% ULTRABAG