BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880741 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04865
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS RESOLVED OVER THE PHONE; NO SAMPLE WAS REQUESTED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF THE PATIENT MOVING THE SUPPLY BAG TO THE HEATER PAN DURING THERAPY IN EFFORTS TO WARM THE SUPPLY BAG. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE NURSE (RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING SOLUTION EMPTYING OUT FROM THE FINAL BAG AND YET THE HEATER BAG WAS FULL ON THE HOMECHOICE (HC) DURING FILL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE RN TO CHECK THE BAG CONNECTIONS. THE RN STATED THE HEATER BAG WAS CONNECTED TO THE LINE WITH THE RED CLAMP AND THE SUPPLY BAG WAS CONNECTED TO THE LINE WITH THE BLUE CLAMP. THE TSR ASKED THE RN WHICH BAG WAS ON THE HC. THE RN STATED THE FINAL BAG WAS ON THE HC AND THE HEATER BAG WAS ON THE SIDE. THE TSR ADVISED THE RN TO PUT THE HEATER BAG ON THE HC AND THE FINAL BAG ON THE SIDE. THE TSR EXPLAINED TO THE RN THE BAG CONNECTED TO THE HEATER LINE SHOULD ALWAYS BE ON THE HC AND NEVER REMOVED. THE TSR EXPLAINED DURING THE DWELL THE SUPPLY OR THE FINAL LINE WOULD REFILL THE HEATER BAG AND THEN FILL THE HP. THE RN CONFIRMED THE HP RESUMED THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR