BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2962463 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03844
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE BY PATIENT DESCRIBED AS HOME PATIENT DID NOT WEAR A MASK WHILE PERFORMING PD THERAPY. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE PATIENT'S WIFE. ON AN UNKNOWN DATE THE HOME PATIENT EXPERIENCED PERITONITIS AND WAS RECOVERING FROM THE EVENT. DURING FOLLOW UP WITH THE PD NURSE (PDN) ADDITIONAL INFORMATION WAS RECEIVED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE OF TOUCH CONTAMINATION (DETAILS NOT PROVIDED) WHICH CAUSED THE PERITONITIS. THE PATIENT EXPERIENCED THE PERITONITIS TWO WEEKS PRIOR TO THE INITIAL REPORT. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. PD THERAPY WITH DIANEAL PD4 AMBUFLEX, LOW CALCIUM, INTRAPERITONEALLY (IP), WAS ONGOING. THE PDN REPORTED THE PATIENT HAD RECOVERED FROM THE PERITONITIS EVENT (DATE UNSPECIFIED). ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED IN PROPER ASEPTIC PROCEDURES FOR PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66024 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other DIANEAL PD4 AMBUFLEX