BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2173532 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09340
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 26, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CONTACTED THE PATIENT REGARDING THE SYSTEM ERROR 2240 ALARM. THE PATIENT STATED THAT SHE WAS OK AND WAS ABLE TO CONTINUE THERAPY. THE PATIENT STATED THE ALARM DID CLEAR AND FOLLOWING INSTRUCTIONS, ALL SUPPLIES WERE DISCARDED. NO SAMPLE WAS AVAILABLE. THE REPORTED PROBLEM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. BAXTER CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM INDICATES AIR ENTERED THE SET UP. THE HP SAID THAT MORE MOISTURE THAN NORMAL WAS UNDER THE SUPPLY BAG. THE TSR ADVISED THE HP TO CYCLE THE POWER TO CLEAR THE ALARM. THE TSR FURTHER ADVISED THE HP TO INFORM THE REGISTERED NURSE (RN) ABOUT THE INCIDENT. THE HP STATED THE RN WAS ALREADY AWARE. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT; THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    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