BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4091310 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31415
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 TITANIUM ADAPTER, (B)(4) ADDRESSES THE TRANSFER SET 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. IT WAS NOT REPORTED WHETHER THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. THE TREATMENT FOR PERITONITIS WAS ALSO NOT REPORTED. THE PATIENT¿S PD CATHETER WAS REMOVED AND THE PD THERAPY WAS DISCONTINUED. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572986 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TRANSFER SET, MINICAP| DIANEAL 1.5%, 2.5% AND EXTRANEAL