BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1955403 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00375
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4). AVAILABILITY OF SAMPLE IS UNKNOWN AT THIS TIME.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)

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 3 OF 4. (B)(4) HAD THE HP RECYCLE POWER AND ADVISED THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES OR DO A MANUAL EXCHANGE. THE HP WOULD DO MANUAL EXCHANGE. (B)(4) ADVISED THE HP TO CONTACT THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) AND INFORM THE PD RN OF THE SE 2240. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING FOLLOW UP, THE HP STATED THAT THERE WERE NO ABNORMALITIES AND THAT SHE JUST STARTED OVER WITH NEW SUPPLIES AND EVERYTHING WAS FINE. THE HP STATED THAT SHE DID NOTIFY HER NURSE.

    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 71 YR HOMECHOICE CYCLER