BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2936199 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02358
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS IS CONFIRMED BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, DESCRIBED AS TOUCH CONTAMINATION, WHICH CAUSED PERITONITIS; HOWEVER, THE CAUSE OF THE USE ERROR COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. 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. 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

    THIS IS A SPONTANEOUS REPORT TO GLOBAL PHARAMACOVIGILANCE (GPV) FROM A NURSE IN THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR GRAM NEGATIVE ORGANISM IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION, WHICH WAS FURTHER DESCRIBED AS PATIENT CONTAMINATED HIS LINE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS GIVEN ANTIBIOTICS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. FOLLOW UP INFORMATION WAS PROVIDED TO GPV BY THE PERITONEAL DIALYSIS NURSE (PDRN) THE PDRN CONFIRMED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN IN HIS ABDOMEN DUE TO THE START OF THE PERITONITIS. THE PATIENT WAS DISCHARGED TO THEIR HOME ON (B)(6) 2012 (NOT (B)(6) 2012 AS PREVIOUSLY REPORTED). THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. RN CLARIFIED THAT 'PATIENT CONTAMINATED HIS LINE' AND TOUCH CONTAMINATION WERE THE SAME. THE PATIENT WAS RETRAINED ON HOW TO PROPERLY PERFORM PD THERAPY. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT. THE PDRN CONFIRMED THAT THE ABDOMINAL PAIN AND PERITONITIS WERE NOT RELATED TO DIANEAL SOLUTIONS, A BAXTER DEVICE, OR DISPOSABLES. THE RN UNABLE TO PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40214 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R DIANEAL PD4 AMBUFLEX