BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2012366 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02955
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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). THIS REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE CONNECTION ISSUE WAS DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING; HOWEVER, THE CAUSE OF THE BAG FALLING WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED 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 FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A FINAL BAG THAT DISCONNECTED DURING DRAIN 2 OF 4 OF THERAPY ON THE HOMECHOICE (HC) MACHINE. THE HP STATED THE FINAL LINE DISCONNECTED FROM THE FINAL BAG AND FELL TO THE FLOOR. THE HP ALSO STATED SHE HAD CLOSED ALL THE CLAMPS AND DISCONNECTED FROM THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO END THERAPY. THE TSR FURTHER ADVISED THE HP TO CONTACT THE NURSE ABOUT MISSED THERAPY. 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 62 YR HOMECHOICE PRO