BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212381 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10733
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA/NCR (B)(4) AND (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THEY HAD NOTICED THAT THE SUPPLY BAG HAD DISCONNECTED. HP TRIED TO RECONNECT THE BAG TO THE LINE AND THE ALARM OCCURRED SHORTLY AFTERWARD. THE HP TURNED THE MACHINE OFF AND DISCONNECTED. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM AND ADVISED TO CONTACT THE RN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE SYSTEM ERROR 2240. THE HP STATED THEY MADE AN ERROR WHEN CONNECTING THE BAG SO IT DID NOT FULLY CONNECT AND CAME LOOSE. THE HP STATED THEY UNDERSTOOD THAT IT IS NOT PROPER PROCEDURE TO RECONNECT WHEN THEY REALIZED THE CONNECTION TO THE BAG WAS NOT COMPLETE. THE HP STATED THEY LET THEIR REGISTERED NURSE (RN) KNOW ABOUT THE ALARM. THE HP STATED THERE WAS NO INJURY OR MEDICAL INTERVENTION.

    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