BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120645 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07461
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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). BAXTER PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE SYSTEM ERROR 2240 ALARM AND THE NURSE STATED THE PATIENT WAS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUES. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING UNKNOWN ALARMS THAT APPEARED ON THE HOME CHOICE (HC). (B)(4) REVIEWED THE ALARM LOG; A SYSTEM ERROR (SE) 2240 WAS IDENTIFIED. (B)(4) ADVISED THE HP TO LET THE NURSE (RN) KNOW ABOUT THE SYSTEM ERROR 2240 AS THIS IS AN INDICATION AIR ENTERED THE SET UP. (B)(4) REVIEWED PROPER PROCEDURES PER THE USER MANUAL. ON (B)(6) 2011 THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE RN AND ADVISED OF THE PATIENT REPORT. THE RN CONFIRMED SHE/HE WOULD FOLLOW UP WITH THE HP. 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 HOMECHOICE PRO