BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2002262 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02497
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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 DWELL 5 OF 8. GTS CLEARED THE ERROR AND INFORMED THE HOME PATIENT (HP) OF THE ERROR'S MEANING. THE HP WOULD CALL THE PERITONEAL DIALYSIS (PD) NURSE FOR INSTRUCTIONS ON WHAT TO DO NEXT. THERE WERE NO LEAKS AND ALL BAGS WERE CONNECTED. THERE WERE FOUR 6L BAGS AND TWO WERE EMPTY. 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. THE WRITER SPOKE WITH THE HOME PATIENT (HP) ON (B)(4) 2011 REGARDING THE REPORTED PROBLEM. THE HP SAID THE LOT NUMBER WAS UNKNOWN AND NO SAMPLES WERE AVAILABLE. THE HP SAID ALL THE SUPPLIES USED AT THE TIME LOOKED ALRIGHT. THE HP DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM OR HOW AIR MIGHT HAVE GOTTEN IN THE LINES. THE HP SAID SHE RECEIVED A BAD BOX OF 1.5% SOLUTION. THE HP SAID THERE WERE LEAKING BAGS AND SHE THREW THE WHOLE BOX AWAY. THE LOT NUMBER WAS UNKNOWN AND NO SAMPLES WERE AVAILABLE. THE WRITER ADVISED THE HP TO KEEP THE BAGS OR WRITE DOWN THE LOT NUMBER AND CALL IN IF SHE RECEIVED ANOTHER BAD BOX. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HC CYCLER