BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141724 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08413
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 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). CORRECTION: THE SAMPLE WAS REQUESTED BUT WAS NOT RETURNED. ADDITIONAL INFORMATION: THE COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A LABELING REVIEW WAS NOT COMPLETED BECAUSE NO USE ERROR WAS SUSPECTED. 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). A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. GTS HELPED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND INFORMED THE HP OF THE ERROR'S MEANING. PER THE HP, THERE WAS SOME AIR IN THE LINE. THE HP SAID SHE CLAMPED THE LINE DURING THE INITIAL DRAIN BECAUSE SHE DID NOT WANT THE AIR TO GO INSIDE HER. THE HP WOULD REPLACE THE SETUP AND RESTART THERAPY. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THE PATIENT WAS INVOLVED BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT. THE PATIENT STATED THAT NOTHING WAS NOTICED WITH THE SUPPLIES AND USING NEW SUPPLIES RESOLVED THE ALARM. THE SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11C26055. THE NURSE WAS NOT CONTACTED REGARDING THE EVENT SO BAXTER ADVISED THE PATIENT TO CONTACT THE NURSE. 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 H11C26055

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR HOMECHOICE