BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223685 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11275
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 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 WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR; PER THE COMPLAINT INFORMATION A PATIENT LINE EXTENSION WAS ADDED AFTER PRIMING OCCURRED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH CAPA/NCR (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A USE ERROR WHICH CAUSED THE SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONFIRMED THAT THE PATIENT LINE EXTENSION WAS ADDED AFTER PRIME. THE TSR HAD THE HOME PATIENT (HP) CLOSE ALL THE CLAMPS TO THE BAGS AND PATIENT LINE, CYCLE THE POWER OFF/ON TWICE, PRESSED GO TO START AND THE HC WAS AT LOAD THE SET. THE HP REMOVED THE CASSETTE. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH NEW SUPPLIES. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE ALARM. THE RN WAS MADE AWARE OF THE HOME PATIENT (HP) CONNECTING THE EXTENSION LINE AFTER PRIMING WHICH CAUSED THE SYSTEM ERROR 2240. THE RN STATED THERE HAS BEEN NO REPORT OF INJURY OR MEDICAL INTERVENTION SINCE THE INCIDENT. THERE WAS PATIENT INVOLVEMENT.

    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 28 YR HOMECHOICE