BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1812849 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02822
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SURVEILLANCE SPOKE WITH PERITONEAL DIALYSIS NURSE (PDN) ON (B)(4) 2010, WHO VERIFIED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT. THE PDN COMMENTED THE CAREGIVER WAS VERY WELL TRAINED IN THE PROPER THERAPY PROCEDURES. THE PDN ALSO COMMENTED THAT THE HP IS NOW ON HEMODIALYSIS AND THE SWITCH TO HEMODIALYSIS WAS NOT RELATED TO ANYTHING WITH THE PD THERAPY. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING THE INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN. THE CAREGIVER (CG) WAS UNSURE IF THE PATIENT LINE WAS FULLY PRIMED WHEN STARTING THE INITIAL DRAIN, BUT THE CAUSE OF THE ALARM WAS UNDETERMINED. THE HOME PATIENT (HP) WOULD RESTART WITH NEW SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) THAT A LEAK OCCURRED FROM THE TRANSFER SET. THE TRANSFER SET HAD BEEN USED FOR ONE MONTH AND IT WAS NOTED THAT LIQUID COULD NOT BE STOPPED EVEN IF CLOSING THE CLAMP. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER REPORTED NO USE OF ANY ADDITIONAL DISINFECTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR