BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1771106 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01661
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 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 AND NO COMPANION SAMPLE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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 (SE) 2240 (INDICATING AIR IN THE SET) WITH THE HOMECHOICE (HC) MACHINE DURING DWELL 1 OF 4. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP WAS ADVISED TO NOTIFY THE REGISTERED NURSE (RN) OF AIR IN THE SET. 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. PRODUCT SURVEILLANCE SPOKE WITH THE HP'S WIFE ON (B)(6) 2010 CONCERNING THE REPORTED EVENT OF A SE 2240 ALARM. THE WIFE STATED THEY TURNED THE HC OFF AND THEN STARTED OVER WITH NEW SUPPLIES, DISCARDING THE SETUP. THE LOT NUMBER WAS UNKNOWN AND NO COMPANION SAMPLES WERE AVAILABLE. THE HP CONTINUED THERAPY USING THE SAME TRANSFER SET WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS LINES GOING THROUGH THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    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 76 YR