BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3231691 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18756
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THERE WAS A BREAK IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS THE ATTENDANT WAS DOING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) WITHOUT PROPER TRAINING AND WAS NOT WEARING A MASK. SUBSEQUENTLY THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INJECTION FORTUM (1GM, DAILY, IP) AND VANCOMYCIN (2GM, WEEKLY, IP) FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PERITONITIS WAS UNKNOWN AND DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331135 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXTRANEAL| DIANEAL PD2 2.5% ULTRABAG