BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2342094 · Received November 18, 2011

    Report

    Report Number
    6000001-2011-38057
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    November 4, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 K961008.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE EVALUATION: THE REPORTED ISSUE OF AN AUTOMIX 3+3 COMPOUNDER FOR WHICH THE CUSTOMER REPORTED "DELIVERED 168ML OVER THE PROGRAMMED AMOUNT" WAS NOT CONFIRMED OR REPRODUCED DURING SERVICE BY BAXTER PERSONNEL. THE ROOT CAUSE WAS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED THAT DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "OVER DELIVERY WITHOUT ALARM".

    Description of Event or Problem · 1

    BAXTER RECEIVED A COMPLAINT FROM A FACILITY INVOLVING THE AUTOMIX 3+3 COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE DELIVERED INACCURATELY. FINAL OUTPUT WAS 168ML OVER THE PROGRAMMED AMOUNT. UNIT IS BEING SWAPPED. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. NO MEDICAL INTERVENTION. 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