BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4221478 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38550
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF THE EVENT IS UNKNOWN, HOWEVER, THE INFORMATION WAS TAKEN FROM ARTICLE DATED 18DEC2013. THE INFORMATION CAME FROM LITERATURE ARTICLE: THOMAS A. FORBES & ANDREW J. LUNN, MONTELUKAST: A NOVEL THERAPEUTIC OPTION IN EOSINOPHILIC PERITONITIS. PEDIATR NEPHROL (2014) 29:1279¿1282. PG. 1281. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DISCONNECTION AND CLOUDY EFFLUENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED AN UNSPECIFIED DISCONNECTION ISSUE AND SUBSEQUENTLY HAD ¿AN ASYMPTOMATIC FLARE IN PD FLUID AND CLOUDY PD EFFLUENT¿ (NO FURTHER DETAILS WERE PROVIDED). IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED OR TREATED FOR THE EVENT OF CLOUDY EFFLUENT SUBSEQUENT TO THE DISCONNECTION ISSUE. ON AN UNREPORTED DATE, THE CLOUDY EFFLUENT WAS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702056 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other DIANEAL 1.36 % AND PHYSIONEAL