BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2963945 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03952
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PATIENT DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD, WHICH CAUSED PERITONITIS. 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 BY A NURSE IN THE USA THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. APPROXIMATELY 5 MONTHS AGO, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE PD NURSE (PDN). ON AN UNREPORTED DATE, THE PATIENT DID NOT CLEAN THE EXCHANGE AREA BEFORE STARTING PD, WHICH LED TO PERITONITIS. ABOUT TWO WEEKS PRIOR TO THIS REPORT, THE PATIENT EXPERIENCED PERITONITIS. APPROXIMATELY TWELVE DAYS AFTER EXPERIENCING THE PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED FOR THE PERITONITIS WITH VANCOMYCIN AND RIFAMPIN (DOSES, FREQUENCIES, AND LOTS NOT REPORTED). CONCOMITANT THERAPY WAS NOT REPORTED. ON AN UNSPECIFIED DATE, WHILE THE PATIENT WAS IN THE HOSPITAL, THE PATIENT'S PD CATHETER WAS REMOVED AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS (HD). THE NURSE STATED THE PATIENT WAS NOT RE-TRAINED IN PROPER ASEPTIC TECHNIQUE BECAUSE THE PATIENT WAS CHANGED TO HD. ON AN UNSPECIFIED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT REMAINS ON HD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68525 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R DIANEAL PD4, 2.5%, LOW CALCIUM, ULTRABAG| DIANEAL PD4, 1.5%, LOW CALCIUM, ULTRABAG