BEUDAMED
    FDA Adverse Event Summary report: N

    KDJ - SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2743182 · Received September 13, 2012

    Report

    Report Number
    1423500-2012-17905
    Date Received
    September 13, 2012
    Date of Event
    July 1, 2012
    Report Date
    August 27, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED, SINCE WE ARE UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND DETERMINED THAT THE INSTRUCTIONS PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING USE ERROR - 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A NURSE IN THE USA OF A BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH DIANEAL THERAPY. DURING A CALL WITH BAXTER HOME CARE SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH CAUSED PERITONITIS. THE HP WAS NOT HOSPITALIZED FOR THE PERITONITIS. FOLLOW-UP WAS PERFORMED WITH THE HP'S RN ON (B)(6) 2012 AND THE FOLLOWING INFORMATION WAS OBTAINED: THE HP'S PERITONITIS STARTED ON (B)(6) 2012. THE HP WAS STARTED ON CEFAZOLIN 2G DAILY X 14 DAYS AND CEFTAZIDIME (DOSAGE UNKNOWN) X 2 DOSES. THE HP WAS STILL EXPERIENCING ABDOMINAL PAIN SO THE HP'S MD SUSPECTED A TUNNELED INFECTION AND HAD THE HP'S CATHETER REMOVED ON (B)(6) 2012. THE HP WAS SWITCHED TO HEMODIALYSIS WHILE HEALING AND HAD A NEW CATHETER PLACED ON (B)(6) 2012. THE HP WILL CONTINUE ON HEMODIALYSIS UNTIL HE SEES HIS SURGEON ON (B)(6) 2012. THE RN STATED THAT THE PERITONITIS WAS IN NO WAY RELATED TO BAXTER'S SOLUTIONS, DISPOSABLES OR DEVICE. THE HP HAS POOR ASEPTIC TECHNIQUE AND HAS RECEIVED 'A NUMBER' OF RETRAINING SESSIONS ON PROPER ASEPTIC TECHNIQUE. THE RN STATED THAT THE PERITONITIS IS RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention GREEN (B)(4) SINGLEBAG LOW CALCIUM