BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930608 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06945
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 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). THE SAMPLE IS NOT AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DRAIN 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 CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) DISCONNECTED TO USE THE BATHROOM. THE DRAIN CYCLE STARTED, AND THE HC ALARMED. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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

    A CAREGIVER (CG) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DRAIN. THE CARE GIVER (CG) STATED THAT THE HOME PATIENT (HP) DISCONNECTED TO USE THE BATHROOM. THE DRAIN CYCLE STARTED AND THE HC ALARMED. (B)(4) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE CG TO RESTART THERAPY WITH NEW SUPPLIES. THE CG CONFIRMED TO START WITH NEW SUPPLIES AND CALL BACK WITH ANY QUESTIONS. ON (B)(6) 2010 (B)(4) SPOKE WITH THE HOME PATIENT (HP) WHO COULD NOT RECALL IF SHE RECONNECTED TO THE SETUP AFTER INTENTIONALLY DISCONNECTING. THE HP STATED HER THERAPY WAS RESUMING WITHOUT COMPLICATIONS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER DETAIL WAS AVAILABLE.

    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 68 YR HOMECHOICE APD CYCLER