BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2150600 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08703
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 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 (SE) 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED; HOWEVER, 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 CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS 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). THE SPECIFIC PRODUCT CODE FOR THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE IS UNKNOWN; THEREFORE, D4 IS UNKNOWN. THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. PER THE INITIAL REPORT, THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE LINE). THE HOME PATIENT (HP) STATED SHE PRESSED THE GO BUTTON ON THE HC TO START THE INITIAL DRAIN AND THEN CONNECTED HERSELF. THE HP STATED A FEW MINUTES LATER THE HC ALARMED SYSTEM ERROR 2240. THE TSR EXPLAINED THE ALARM AND THEN EXPLAINED THE PROPER SETUP PROCEDURES PER THE USER MANUAL. THE TSR ASSISTED THE HP TO CYCLE THE HC OFF/ON TWICE TO CLEAR THE ALARMS AND EXPLAINED TO START OVER WITH NEW SUPPLIES. (B)(4) CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HP STATED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES. THE CAUSE OF ALARM WAS DUE TO THE HP PRESSING GO TO START INITIAL DRAIN AND THEN CONNECTING. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER THE HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES.

    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 38 YR HOMECHOICE