BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2221589 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20520
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS DEVICE IS CLASS II EXEMPT FROM HAVING A 510(K) NUMBER. ITS ADDITIONAL 510(K) NUMBER IS K955622.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF OVER DELIVERY WITHOUT ALARM, OTHER WAS NOT CONFIRMED. THE VISUAL EXAMINATION OF THE UNIT DID NOT CONFIRM THE ISSUE. THE ROOT CAUSE WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE'S GRAY STATION WAS RUNNING OUT TO EARLY. GRAY STATION WAS RUNNING 660 ML POOL IN THE SOURCE CONTAINER WITH A PROGRAMMED AMOUNT OF 89ML. THE SPECIFIC GRAVITY THAT HAD BEEN SET WAS AN AVERAGE OF 1.11. THE CUSTOMER INVOLVED MEDICAL INFORMATION FOR SPECIFIC GRAVITY. THEY DID THE MATH AND INFORMED CUSTOMER THAT THE SPECIFIC GRAVITY BY THE MATH SHOULD BE 1.16. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUNDERS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1