BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4052122 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29258
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 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). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. THIS REPORT IS FOR AN UNKNOWN TRANSFER SET, WHILE (B)(4) ADDRESSES THE TITANIUM ADAPTER REPORT AND (B)(4) ADDRESSES THE MINICAP REPORT FOR THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS, COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED DUE TO THE REPORTED EVENT. THE TREATMENT FOR THE PERITONITIS INCLUDED INJECTION (INJ) OF VANCOMYCIN (1GRAM, STAT DOSE, ROUTE NOT REPORTED), INJ. OF INTRAPERITONEAL (IP) AMIKACIN (500 MILLIGRAMS STAT DOSE, AND 100 MILLIGRAMS ONCE PER DAY) AND INJ. OF FORTUM (1GRAM, ONCE PER DAY, ROUTE NOT REPORTED). THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533362 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R DIANEAL 2.5% ULTRABAG, TITANIUM ADAPTER, MINICAP