BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2212496 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-18992
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. VISUAL EXAMINATION OF THE SAMPLE SHOWED NO SIGN OF PHYSICAL ABNORMALITY. THE UNIT WAS SUBSEQUENTLY LEAK TESTED. LEAK WAS NOTED AT THE JUNCTION OF THE TUBING AND THE STRESS-MEMBER. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT BONDING AT THE SEAL BETWEEN THE TUBING AND STRESS MEMBER. ACTION WAS INITIATED TO IMPROVE THE STRESS MEMBER AND RESTRICTOR HOUSING. A LONGER SEAL LENGTH RESULTS IN A LARGER CONTACT SURFACE FOR SOLVENT TO BOND AND HENCE A LOWER CHANCE OF LEAK. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING EVALUATION BY BAXTER PERSONNEL, AN INTERMATE WAS FOUND TO LEAK FROM THE JUNCTION OF THE TUBING AND THE STRESS-MEMBER BECAUSE THE TUBING HAD COMPLETELY DETACHED ITSELF FROM THE STRESS-MEMBER DURING FILL. TRACES OF SOLVENT WERE NOTED ON THE TUBING. THIS CONDITION OCCURRED DURING EVALUATION. 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 11E005

    Patients

    Seq Age Sex Outcome Treatment
    1