BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2963630 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03922
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 23, 2012
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL INFORMATION, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE AND RECOVERED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. THIS REPORT OF PERITONITIS CAUSED BY A USE ERROR-BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED BECAUSE THE PATIENT REPORTED A BREACH IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT TOUCHED STICKY PARTICULATE MATTER ON THE OUTSIDE OF A DIANEAL SOLUTION BAG, WHICH CAUSED PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING MANUAL PERITONEAL DIALYSIS THERAPY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE FOR THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IN THE USA TOUCHED STICKY PARTICULATE MATTER ON THE OUTSIDE OF A DIANEAL SOLUTION BAG AND EXPERIENCED PERITONITIS. THE PATIENT BELIEVED THE PERITONITIS WAS CAUSED BY TOUCHING THE PARTICULATE MATTER ON THE OUTSIDE OF A DIANEAL SOLUTION BAG. THE PATIENT WAS HOSPITALIZED SEVEN DAYS FOR THE EVENT. TREATMENT WAS NOT REPORTED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE OUTCOME FOR THE EVENT OF THE PATIENT TOUCHED STICKY PARTICULATE MATTER ON THE OUTSIDE OF THE SOLUTION BAG WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68957 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization DIANEAL PD4 ULTRABAG