BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223689 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11277
    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). 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.

    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 CLAMP WAS OPEN ON AN UNUSED LINE. 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).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING USE ERROR CAUSING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING DWELL 3 OF 4 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) HAD 2 BAGS CONNECTED AND THE UNUSED CLAMP LINE WAS OPEN. THE HP CYCLE THE POWER AND WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THE ALARM CLEARED. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN). THE RN WAS MADE AWARE THAT THE HOME PATIENT (HP) LEFT A CLAMP OPENING CAUSING THE AIR TO ENTER THE SETUP. THE RN STATED THE HP HAS HAD NO 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 46 YR HOMECHOICE