BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2942209 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02847
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 130 ML OF SOLUTION. THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT NOTED EXCESSIVE DRUG PRECIPITATE BLOCKING THE END OF THE GLASS CAPILLARY (FLUID PATHWAY) LOCATED INSIDE THE FLOW RESTRICTOR. THE ROOT CAUSE WAS DETERMINED TO BE DRUG CRYSTALLIZATION AT THE END OF THE GLASS CAPILLARY. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. 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

    ON (B)(6) 2013, THE CUSTOMER CONTACTED BAXTER TO REPORT THAT AN INCIDENT OF NO FLOW OCCURRED WITH AN INFUSOR. THE INFUSOR DID NOT DELIVER THE DRUG AT ALL OVER FIVE DAYS. THE INCIDENT OCCURRED DURING PATIENT USE; HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS REPORTED TO BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46825 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11M056

    Patients

    Seq Age Sex Outcome Treatment
    1