BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2140996 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08380
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 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). CORRECTION: INFORMATION ERRONEOUSLY OMITTED FROM THE INITIAL AND FIRST FOLLOW-UP MEDWATCHES: THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 OCCURRED DURING FILL 1 AND WAS NOT CONFIRMED IN THE LAB WITH THE COMPANION SAMPLE. A BATCH REVIEW WAS PERFORMED WITH THE LOT NUMBER PROVIDED BY THE CUSTOMER, BUT NO ISSUES WERE NOTED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF A COMPANION SAMPLE WAS MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING FILL 1. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO END THERAPY AND START OVER WITH ALL NEW SUPPLIES. THE TSR OFFERED ASSISTANCE WITH ENDING THERAPY, AND THE HP STATED NO AND HUNG UP THE PHONE. BAXTER CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: NOTHING WAS NOTICED WITH THE SUPPLIES AND USING NEW SUPPLIES RESOLVED THE ALARM. THE CASSETTE WAS DISCARDED AND A COMPANION CASSETTE WAS REQUESTED. THE LOT NUMBER WAS NOT AVAILABLE AS THE PATIENT WAS NOT AT HOME. THE NURSE WAS NOT CONTACTED REGARDING THE EVENT BUT THE PATIENT STATED SHE WAS GOING IN TO SEE HER THURSDAY AND WOULD REPORT THE EVENT THEN. 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 37 YR HOMECHOICE