BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2260946 · Received September 23, 2011

    Report

    Report Number
    6000001-2011-26463
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION THERE IS NO INFORMATION TO SUGGEST THAT THIS DEVICE MALFUNCTION WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL NARRATIVE: 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.

    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 HAD INCORRECT SOLUTION 2 ALARM WHICH OCCURRED MULTIPLE TIMES OVER THE LAST TWO (2) MONTHS DURING COMPOUNDING. 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