BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2983649 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04983
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT EVENT DATE IS UNKNOWN, HOWEVER THE EVENT IS KNOWN TO HAVE OCCURRED IN (B)(6) 2013. THE CONDITION FOR THE CONNECTION ISSUE WAS NOT CONFIRMED, AS A BATCH REVIEW COULD NOT BE PERFORMED AND THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE PATIENT REPORTED THAT THE PATIENT LINE ACCIDENTALLY DISCONNECTED, BUT THERE IS NOT ENOUGH INFORMATION IN THE EVENT DESCRIPTION TO DETERMINE AN ASSIGNABLE CAUSE CODE FOR THIS CONNECTION ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED REGARDING A CONNECTION ISSUE, WHICH LEAD TO PERITONITIS IN A PATIENT, COINCIDENT WITH DIANEAL THERAPY. ON AN UNREPORTED DATE, THE PATIENT WAS SLEEPING AND THE TUBING CAME APART. LATER, THE HP WAS DIAGNOSED WITH PERITONITIS, HOWEVER THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS. HOWEVER THE TREATMENT WAS REPORTED AS VANCOMYCIN INTRAPERITONEALLY (IP) (FREQUENCY AND DOSE NOT REPORTED) AND GENTAMICIN IP (FREQUENCY AND DOSE NOT REPORTED). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87592 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention