BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2113441 · Received June 3, 2011

    Report

    Report Number
    1423500-2011-07048
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 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 SAMPLE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SE 2240 ALARM WAS CONFIRMED TO BE CAUSED BY USE ERROR BASED ON CUSTOMER CONTACT. SPECIFICALLY, THE CUSTOMER STATED THAT THE HEATER BAG BECAME DISCONNECTED DURING THERAPY. THE ROOT CAUSE IS USE ERROR. 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. 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 THROUGH (B)(4).

    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 DURING FILL 4 OF 4. THE HOME PATIENT (HP) STATED THAT THE HEATER BAG CAME UNDONE. PER THE HP, HE DISCONNECTED AND TURNED THE HC OFF. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE HP WOULD CALL THE NURSE TO SEE IF IT IS OK TO SKIP THE LAST FILL. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP, THE HP SAID THAT A BAG DID NOT FALL. THE HP SAID IT WAS JUST A SYSTEM ERROR. THE WRITER ASKED IF THERE WAS ANYTHING UNUSUAL WITH THE SUPPLIES, AND THE HP STATED NO, THERE WAS A JUST A SYSTEM ERROR. NO ADDITIONAL INFORMATION COULD BE OBTAINED. 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 58 YR HOMECHOICE