BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1982306 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01683
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 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 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 BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. 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 (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 1 OF 4. THE HP STATED THE SPIKE CAME OUT OF THE SUPPLY BAG AND THE LINE ON THE ORGANIZER THAT SHE DOES NOT USE IS OPEN. (B)(4) THEN EXPLAINED THE PROPER SET PROCEDURES. (B)(4) ASSISTED THE HP TO CYCLE POWER OFF AND ON TWICE TO CLEAR THE ALARM AND EXPLAINED THE ALARM. THE HP STATED SHE WILL NOW START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. DURING FOLLOW UP, THE HP STATED THAT SHE DOES NOT RECALL THE SPECIFIC DETAILS OF THE REPORTED PROBLEM. SHE STATED THAT SHE STARTED OVER WITH NEW SUPPLIES. SHE DOES NOT HAVE ANY FURTHER INFORMATION REGARDING THE PRODUCTS AND STATED THAT SHE HAS HAD SOME DIFFICULTY WITH SETTING UP THE HC. SHE STATED SHE HAS POOR EYESIGHT AND THAT WAS PROBABLY WHY THE SPIKE CAME LOOSE FROM THE BAG. SHE STATED THAT EVERYTHING IS GOING OKAY AND REPORTED NO INJURY OR MEDICAL INTERVENTION.

    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 HC CYCLER