BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2222257 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11204
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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). THE REPORTED SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS INCOMPLETE PRIME. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW WILL BE PERFORMED. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING A SYSTEM ERROR 2240 ALARM WITH THE HOMECHOICE (HC) MACHINE DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE AND ADVISED THE HOME PATIENT (HP) TO RECYCLE POWER TO THE HC AND START OVER WITH NEW SUPPLIES. THERE WAS NO REASON FOUND FOR THE ALARM. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HP RETURNED THE CALL MADE BY PRODUCT SURVEILLANCE REGARDING THE REPORTED EVENT. THE HP STATED THE CAUSE OF THE ALARM WAS THAT SHE WAS USING TWO PATIENT LINE EXTENSIONS AND WAS NOT ABLE TO COMPLETELY PRIME THE SETUP. THE HP TRIED TO RE-PRIME THE LINES BUT WAS UNSUCCESSFUL. THE HP ADVISED THAT SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. 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 65 YR HOMECHOICE