BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1973414 · Received January 30, 2011

    Report

    Report Number
    1423500-2011-01267
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 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). 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. 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. 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 BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR (SE) 2240 THAT OCCURRED DURING THE PREVIOUS THERAPY. THE HOME PATIENT (HP) SAID THAT DURING THE PREVIOUS THERAPY THE SUPPLY BAG FELL AND DISCONNECTED. THE HP SET UP WITH NEW SUPPLIES AND RESTARTED THERAPY. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED TO LET THE REGISTERED NURSE (RN) KNOW THE HP GOT THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP CALL THE HP STATED THAT THE SUPPLY BAG FELL BETWEEN THE TABLE AND THE WALL AND THE HP USUALLY HAS THE TABLE UP AGAINST THE WALL. THE HP STATED THE HP WAS ASLEEP AND HEARD THE ALARM, THE HP USUALLY JUST TURNS OVER AND THE ALARM STOPS. THE ALARM DID NOT STOP WHEN THE HP TURNED OVER; THE HP THEN WOKE UP AND NOTICED THE LINE POPPED OUT OF THE BAG. THE HP SHUT EVERYTHING OFF, DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW SUPPLIES. THE HP STATED HE CALLED THE PERITONEAL DIALYSIS NURSE THE FOLLOWING MORNING AND THE NURSE ASKED THE HP TO CALL BACK IF THE HP HAD A FEVER OR STOMACH PAIN. THE HP STATED HE CHANGED THE WAY HE SETS UP THE BAGS. THE HP STATED HE IS USING NEW CASES AND THE LOT NUMBER WAS NOT KNOWN. THE HP RESUMED THERAPY WITHOUT ANY PROBLEMS WITH THE NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE CYCLER