BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUNDERS

    MDR report key: 2152976 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10795
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER REVIEW BY BAXTER HAS CONCLUDED THAT THE REPORTED CONDITION, OF INCORRECT SOLUTION ALARM, IS UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO REOCCUR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER IN THE WAREHOUSE FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE. THIS DEVICE IS 510K EXEMPT CLASS (II).

    Description of Event or Problem · 1

    BAXTER RECEIVED A COMPLAINT FROM A USER FACILITY INVOLVING THE AUTOMIX 3+3/AS COMPOUNDER. ACCORDING TO THE FACILITY, THE DEVICE GENERATED AN INCORRECT SOLUTION ALARM DURING COMPOUNDING. THERE WAS NO PATIENT IMPACT. THERE WAS NO PATIENT INVOLVEMENT. NO MEDICAL INTERVENTION. THE DEVICE IS AVAILABLE FOR EVALUATION. 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