BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1980852 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01581
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE TRANSFER SET WAS NOT CONNECTED TIGHT TO PATIENT LINE. THE PATIENT STATED THE TRANSFER SET CONNECTION WAS LOOSE AND THAT SHE CLOSED IT DURING THE INITIAL DRAIN. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE PATIENT STATED THE TRANSFER SET CONNECTION WAS LOOSE AND THAT SHE CLOSED IT DURING THE INITIAL DRAIN. (B)(4) ADVISED THE PATIENT IF THE CONNECTION WAS LOOSE, AIR COULD ENTER THE SETUP AND THAT THEY MUST MAKE SURE THE CONNECTION IS TIGHT. (B)(4) EXPLAINED THE ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. (B)(4) THEN HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. (B)(4) THEN ADVISED THE PATIENT THAT THERAPY HAD ENDED AND THEY'D NEED TO START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 69 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)