BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1802022 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02561
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 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 SAMPLE IS NOT AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK PATIENT LINE ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE WAS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A CHECK PATIENT LINE ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING STEPS. THE HP STATED THAT THERE WERE LARGE GAPS OF AIR IN THE PATIENT LINE. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR EXPLAINED TO THE HP THE IMPORTANCE OF MAKING SURE THAT THE PATIENT LINE WAS FULLY PRIMED BEFORE CONNECTING. THE HP CONFIRMED SHE UNDERSTOOD EXPLANATION AND WOULD START OVER WITH NEW SUPPLIES. ON (B)(6) 2010, (B)(4) SPOKE WITH A NURSE (RN) AT THE HP'S DIALYSIS FACILITY WHO STATED THE NURSING STAFF AT THE CLINIC WAS IN CLOSE CONTACT WITH THE HP. THE RN STATED THE HP HAD BEEN HAVING ISSUE WITH FIBRIN; THE RN BELIEVED THE ISSUE WAS RESOLVED. NO OTHER ISSUES/PROBLEMS WITH THERAPY OR PRODUCT SUPPLIES HAVE BEEN REPORTED; THE RN CONFIRMED THE HP WAS DOING FINE WITH THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 297 MG/DL AND 131 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. HIGH BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER HAD TAKEN INSULIN AFTER TESTING 297 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 71 YR