BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2160236 · Received July 13, 2011

    Report

    Report Number
    1423500-2011-08990
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR WAS NOT CONFIRMED; HOWEVER, THE CAUSE IS THE PATIENT DID NOT PROPERLY DISCONNECT THE PATIENT LINE FROM THE TRANSFER SET DURING THERAPY. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 5 OF 5, THE HOME PATIENT (HP) REVEALED THAT HE HAD THOUGHT THAT THE THERAPY WAS OVER AND DISCONNECTED, THE HC MACHINE ALARMED AND THE HP THEN RECONNECTED HIMSELF. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ISSUE; THE HP DID NOT CAP THE PATIENT LINE WHEN DISCONNECTED. THE TSR THEN ASSISTED THE HP TO END THERAPY. THE HP WOULD FOLLOW UP WITH MANUAL EXCHANGE AND NOTIFY THE NURSE ABOUT DISCONNECTING AND RECONNECTING. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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