BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3011211 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06583
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS EVENT WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING 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 OF THE REPORTED EVENT WAS USE ERROR. 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 HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD), WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT DID NOT WASH THEIR HANDS WELL AFTER CLEANING AND EATING LOBSTER AND CRAB. THE PATIENT EXPERIENCED PERITONITIS BUT WAS NOT HOSPITALIZED. TREATMENT FOR THE PERITONITIS INCLUDED GENTAMYCIN, INTRA-PERITONEALLY (DOSE AND FREQUENCY WERE UNKNOWN). PD THERAPY WAS ONGOING. THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT. LATER, THE PATIENT WAS HOSPITALIZED FOR A BLOOD CLOT. TREATMENT WAS NOT REPORTED BUT THE PATIENT WAS DISCHARGED AND IS RECOVERING FROM THE BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113372 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention DIANEAL 2.5% ULTRABAG| HOMECHOICE| DIANEAL 4.25% SINGLEBAG| DIANEAL 2.5% SINGLEBAG| DIANEAL 1.5% SINGLEBAG| DIANEAL 4.25% ULTRABAG