BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4092831 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31474
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THREE DAYS PRIOR TO THE RECEIPT OF THIS REPORT, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS DIAGNOSIS, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH VANCOMYCIN (DOSE UNKNOWN) IP-INTRAPERITONEALLY. TREATMENT WITH VANCOMYCIN WAS ONGOING AT THE TIME OF THIS REPORT. ON THE SAME DATE, THE PATIENT ALSO RECEIVED ONE DOSE OF CEFEPIME 2000 MG, IP. AFTER THAT DOSE, THE CEFEPIME WAS DISCONTINUED DUE TO THE CULTURE RESULTS. TWO DAYS AFTER DIAGNOSIS, THE PATIENT RECEIVED HIS LAST PD THERAPY TREATMENT AND THE NEXT DAY THE PATIENT WAS SCHEDULED TO HAVE HIS PD CATHETER REMOVED. ON AN UNREPORTED DATE AFTER PD CATHETER REMOVAL, THE PATIENT WOULD BE SWITCHED TO HEMODIALYSIS (HD) THERAPY. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571385 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention TITANIUM ADAPTER & MINICAP| DIANEAL (UNSPECIFIED)