BEUDAMED
    FDA Adverse Event Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962045 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00664
    Date Received
    January 17, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 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 (B)(6) 2011; HOWEVER, DUE TO A FAILED ACK3, THIS MDR IS BEING RESUBMITTED ON (B)(6) 2011. 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 CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR 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, WHICH APPEARED ON THE HOME CHOICE (HC) DURING DRAIN 1 OF 7. THE HOME PATIENT (HP) NEEDED TO USE THE BATHROOM, SO SHE DISCONNECTED HERSELF AND DID NOT PRESS THE STOP BUTTON AND RECONNECTED AFTER THE HC ALARMED. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) EXPLAINED ALL PROPER DISCONNECT PROCEDURES TO THE HP. THE TSR THEN ASSISTED THE HP TO CYCLE POWER OFF/ON TO CLEAR THE ALARM AND THEN EXPLAINED TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HP CONFIRMED THAT SHE DID DISCONNECT TO USE THE REST ROOM WITHOUT PRESSING STOP AND DID COME BACK AND CONNECT. THE HP STATED THAT SHE STARTED OVER WITH NEW SUPPLIES AND DISCARDED THE OLD SUPPLIES AND HAS SINCE STARTED WITH A NEW BOX OF CASSETTES SO A LOT NUMBER IS NOT KNOWN. THE HP STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED.

    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 52 YR HC CYCLER