BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2242203 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23823
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY NO SOLUTION IN THE RESERVOIR. THE DISTAL LUER WAS NOT RETURNED WITH THE UNIT FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF DISTAL LUER BROKEN AT THE JUNCTION OF THE LUER POST. BASED ON THE EVALUATION, BROKEN/CRACKED LUER NEAR THE BASE OF THE STEM IS DUE TO STRESS FROM THE PACKAGING DESIGN. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE SAMPLE.

    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. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NONCONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED VIA PHONE THAT AN INTERMATE HAD THE WHITE FLOW RESTRICTOR BREAK COMPLETELY OFF OF THE TUBING BEFORE PATIENT USE. THE DEVICE WAS FILLED WITH A SOLUTION OF VANCOMYCIN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11E028

    Patients

    Seq Age Sex Outcome Treatment
    1