BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2091964 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06116
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 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 AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. AS PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 AND SE 2367 WHICH OCCURRED ON HOME CHOICE (HC) DURING DWELL. THE HOME PATIENT (HP) STATED THAT SHE WAS NOT CONNECTED DURING DWELL AND THEN THE HC WENT TO DRAIN AND ALARMED SE 2240. THE HP RECYCLED POWER AND THE HC ALARMED SE 2367. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARMS. THE TSR HAD THE HP RECYCLE POWER AGAIN. THE ALARM CLEARED. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL. DURING TROUBLESHOOTING, THE TSR DOCUMENTED THAT THE HP PULLED AND INADVERTENTLY SEPARATED THE PATIENT LINE FROM THE TRANSFER SET AND THEN PRESSED "GO" TO START THERAPY BEFORE CONNECTING . THE TSR REVIEWED PROPER PROCEDURES AS PER THE USER MANUAL. THE HP WILL DISCARD SUPPLIES. THERE WAS PATIENT INVOLVEMENT. 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 80 YR HOMECHOICE PRO