BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2862249 · Received December 7, 2012

    Report

    Report Number
    1416980-2012-06658
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD LEAKED INSIDE AFTER FILLING. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12F079

    Patients

    Seq Age Sex Outcome Treatment
    1