BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1823532 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03110
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE WAS DETERMINED TO BE USE ERROR. A BATCH REVIEW WAS NOT PERFORMED FOR THE TRANSFER SET AS NO LOT NUMBERS WERE AVAILABLE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS THE FIFTH COMPLAINT OF FIVE ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) IN A PATIENT WHILE RECEIVING PERITONEAL DIALYSIS (PD) THERAPY. THIS CASE WAS INITIALLY RECEIVED BY BAXTER CUSTOMER SERVICE FROM THE CONSUMER. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND SEVERE ABDOMINAL PAIN. ON THE SAME DATE, THE PATIENT WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT STARTED THERAPY WITH VANCOMYCIN, CEFTAZIDIME AND MEROPENEM (DOSE, ROUTE AND FREQUENCY WERE NOT REPORTED) FOR PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS RELEASED FROM THE HOSPITAL. AUTOMATED PD TREATMENT REMAINED UNCHANGED. THE NURSE REPORTED THAT THE PATIENT DOES NOT REUSE SOLUTIONS AND IT WAS UNKNOWN IF THERE WAS BREAK IN ASEPTIC TECHNIQUE. THE PATIENT HAD NO CATHETER INFECTION OR PREVIOUS PERITONITIS EPISODES IN THE LAST 4 WEEKS. THE NURSE REPORTED THAT THE PATIENT WAS RECOVERING AT THE TIME OF THIS REPORT. THE REPORTING NURSE CONSIDERED THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) TO BE UNRELATED TO EXTRANEAL AND PHYSIONEAL VIAFLEX THERAPIES.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A NURSE REGARDING PERITONITIS IN A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD) PATIENT. ON (B)(6) 2010 THE NURSE REPORTED THAT THE PATIENT HAD PERITONITIS AND HIS CATHETER WAS REMOVED. THE PATIENT IS NOW ON HEMODIALYSIS. ON (B)(6) 2010, ADDITIONAL INFORMATION WAS OBTAINED FROM THE DIALYSIS NURSE. THE PATIENT HAD BEEN DIAGNOSED WITH FUNGAL PERITONITIS ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED. THE PATIENT HAD THE PD CATHETER REMOVED AND WAS STARTED ON HEMODIALYSIS. THE PD EFFLUENT WAS ANALYZED ON (B)(6) 2010 AND THE WHITE BLOOD CELL COUNT WAS 4086 MM3 AND WAS DETERMINED TO BE FUNGAL PERITONITIS. IT IS UNKNOWN WHAT TREATMENT THE PATIENT RECEIVED FOR THE PERITONITIS. THE NURSE STATED THE PERITONITIS WAS DUE TO TOUCH CONTAMINATION AND THAT IT WAS NOT RELATED TO ANY BAXTER PRODUCTS OR SOLUTIONS. RETRAINING WAS NOT PERFORMED AS THE PD CATHETER WAS REMOVED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. PAST MEDICAL HISTORY INCLUDES END STAGE RENAL DISEASE, HYPERTENSION, DIABETES, HEART DISEASE, CONGESTIVE HEART FAILURE, PNEUMONIA AND A FOOT ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention DIANEAL LOW CAL, ULTRA BAG DEXTROSE 1.50% DIANEAL