BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013232 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-02975
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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 COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE, THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. 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). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY. THE HOME PATIENT (HP) DID NOT CONNECT THE PATIENT LINE EXTENSION UNTIL AFTER PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER TO. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE NURSE SAID THAT SHE WAS AWARE OF THE ISSUE. THE USE ERROR WAS EXPLAINED AND THE NURSE SAID THE HOME PATIENT (HP) TOLD HER IT WAS BECAUSE OF THE HOME CHOICE (HC) SO THE NURSE THANKED THE WRITER FOR THE INFORMATION. THE NURSE SAID THE HP HAS BEEN SEEN SINCE THIS REPORT AND EVERYTHING WAS FINE WITH HIM. 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 62 YR HOMECHOICE CYCLER