BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3180750 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16044
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PERITONEAL EFFLUENT CULTURE RESULT WAS POSITIVE FOR GRAM POSITIVE BACTERIA. THE PATIENT HAD RECOVERED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. THE CAUSE OF PERITONITIS WAS A DISCONNECTION OF THE TITANIUM ADAPTOR FROM A NON-BAXTER CATHETER. THE HP WAS TREATED WITH CIPROFLOXACIN (ROUTE, DOSE, AND FREQUENCY NOT REPORTED) . NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280015 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R UNKNOWN CATHETER| DIANEAL PD4 AMBUFLEX