BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1951716 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00210
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    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 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. 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).

    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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT. THE HOME PATIENT (HP) WAS STILL CONNECTED. ONE OF THE SUPPLY BAGS FELL AND BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HP AND ASSISTED TO CYCLE POWER TO THE HC MACHINE. THE HP WOULD FINISH WITH MANUALS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE HOME PATIENT (HP), THE HP STATED THAT SHE WAS AT A HOTEL AND SHE MOVED THE LAMP AND THINGS ON THE NIGHTSTAND SO SHE COULD SET UP FOR THERAPY. THE HP STATED THAT THE NIGHT STAND WAS KIND OF TALL SO SHE COULD NOT PUT THE BAG ON THE FLOOR SO SHE PUT THE CYCLER ON THE NIGHTSTAND AND PUT THE SOLUTION BAG BEHIND IT. THE HP STATED THAT THE ONLY THING SHE COULD THINK OF IS THAT WHEN THE CYCLER WAS PULLING SOLUTION FROM THE SUPPLY BAG, IT PULLED ENOUGH FOR THE BAG TO FALL AND THEN THE BAG BECAME DISCONNECTED. THE HP STATED THAT SHE STARTED OVER WITH NEW SUPPLIES TO FINISH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HC CYCLER