BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1823533 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03111
    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
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10E22043 AND H10E04017 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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 FOURTH OF FIVE COMPLAINTS ASSOCIATED WITH THIS EVENT.

    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.

    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. (B)(6) 2010, ADDITIONAL INFORMATION WAS OBTAINED FROM THE DIALYSIS NURSE. THE PATIENT HAD BEEN DIAGNOSED WITH (B)(6) 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 (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT FELL "SEVERAL" TIMES AND BROKE HER NECK. THE INS WAS REPLACED DUE TO THE FALLS. ALSO, THE INTERSTIM ICON DVD DID NOT WORK. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET EASYLOCK CONNECTOR 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