BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2241385 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11955
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 25, 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). ADDITIONAL INFORMATION: DURING A FOLLOW-UP WITH THE PATIENT, IT WAS FOUND THAT THE SAMPLE WAS NO LONGER AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 WAS AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE OF A LOOSE CONNECTION BETWEEN THE SUPPLY BAG AND THE LINE, WHICH IS A USE ERROR THAT COULD CAUSE SYSTEM ERROR 2240 ALARMS. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA.

    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 BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR 2240 (AIR IN LINE), THIS SYSTEM ERROR OCCURRED DURING USE. THE PATIENT WAS ADVISED TO DISPOSE OF CURRENT SUPPLIES AND START OVER WITH EITHER NEW SUPPLIES OR COMPLETE MANUAL BAGS FOR THE REST OF THE NIGHT. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE CAREGIVER ON (B)(4) 2011. THE CAUSE WAS UNKNOWN AND NEW SUPPLIES WERE USED TO COMPLETE THERAPY. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11E01053. 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 H11E01053

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOME CHOICE