BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2161064 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08999
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 2 OF 4 WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE REPORT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240 (AIR IN THE SET), DURING DRAIN 2 OF 4. THE HOME PATIENT (HP) DID NOT DISCONNECT AND THERE WAS NO SOLUTION BAG DISCONNECTION. THE HP HAD TWO BAGS CONNECTED AND THE UNUSED CLAMP LINES WERE CLOSED. THE TRANSFER SET WAS TIGHTLY CONNECTED. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE (TSR) ADVISED THE HP TO CONTACT THE REGISTERED NURSE (RN). BAXTER PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(4) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, HE DID NOT DISCONNECT AT ANY POINT AND THE SET UP LOOKED TO BE OKAY. THE HP STATED HE STARTED OVER WITH NEW SUPPLIES AND RESUMED THERAPY WITHOUT ANY PROBLEMS. THE HP LET THE RN KNOW ABOUT THE ALARM. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE