BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2202242 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10576
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 ALARM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING A SYSTEM ERROR 2240 AND 2367 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING DWELL 4 OF 6 THE PREVIOUS NIGHT WHILE CONNECTED. THE ALARM WAS CLEARED PRIOR TO CALLING. THE CARE GIVER (CG) FOUND THE TOWEL UNDER THE SUPPLY BAG WAS DAMP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CALL THE NURSE TO REPORT THE PATIENT WAS CONNECTED DURING THE ALARM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE CG REGARDING THE REPORTED EVENT. THE CG STATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE BAGS OR THE CASSETTE LINES THAT WERE IN USE. THE CG STATED SHE CONTACTED THE PERITONEAL DIALYSIS (PD) NURSE THE DAY THE ALARM OCCURRED AND ALSO HAD A CLINIC VISIT. THE PD NURSE ADVISED THE CG TO MONITOR THE HOME PATIENT (HP) FOR ANY FEVER, CRAMPS OR CLOUDY EFFLUENT. PER THE CG, THE HP HAS NOT HAD ANY SYMPTOMS AND IS DOING WELL ON THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 74 YR HOMECHOICE