BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2991191 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05379
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORT OF PERITONITIS AND A USE ERROR-BREACH IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT RECONNECTING THE TRANSFER SET AND TITANIUM ADAPTOR AFTER THE TWO DEVICES DISCONNECTED, 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 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

    (B)(4). THIS IS A REPORT OF A BREACH IN ASEPTIC TECHNIQUE AND SUBSEQUENT DIAGNOSIS OF PERITONITIS IN A HOME PATIENT (HP). THE HP'S REGISTERED NURSE REPORTED THE HP EXPERIENCED AN UNINTENTIONAL DISCONNECTION OF THE TRANSFER SET FROM THE TITANIUM ADAPTER DURING PERITONEAL DIALYSIS (PD), AFTER WHICH THE HP THEN RECONNECTED THE TRANSFER SET TO THE TITANIUM ADAPTER. THE HP UNDERWENT OUTPATIENT SURGERY TO ADJUST THE PD CATHETER AND CLOUDY EFFLUENT WAS NOTED. ON THE SAME DAY, THE HP WAS DIAGNOSED WITH PERITONITIS. THE HP WAS NOT HOSPITALIZED FOR THE EVENT BUT WAS TREATED WITH VANCOMYCIN (DOSE, ROUTE AND FREQUENCY NOT REPORTED). THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED. IT IS UNKNOWN IF THE PATIENT WAS RE-TRAINED ON PROPER ASEPTIC PROCEDURES. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95847 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DIANEAL LOW CALCIUM| HOMECHOICE