BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1962112 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00636
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 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 MDR WAS SUBMITTED ON 01/14/2011; HOWEVER, DUE TO A FAILED ACK3, THIS MDR IS BEING RESUBMITTED ON 01/17/2011. 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. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    WHILE REVIEWING AN ALARM WITH THE HOME PATIENT (HP), THE HP STATED THAT HE HAD RECEIVED AN ALARM THE PREVIOUS NIGHT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CHECK THE ALARM LOG AND FOUND A SYSTEM ERROR (SE) 2240. THE TSR EXPLAINED THE ALARM AND SUGGESTED THE HP CALL WHEN HAVING THE ISSUE WITH THE MACHINE SO THAT BAXTER CAN TROUBLESHOOT AND HELP THE HP WITH THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP WITH THE HP, HE STATED THAT HE JUST STARTED OVER WITH NEW SUPPLIES AND EVERYTHING WORKED FINE AFTER THAT. THE HP STATED THAT HE DID NOT NOTICE ANYTHING WRONG WITH THE SUPPLIES. THE HP STATED THAT HE DID NOTIFY HIS NURSE.

    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 73 YR HOMECHOICE CYCLER