BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3022767 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07366
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ISSUE OF A NO FLOW WAS DETERMINED TO BE RELATED TO USER TECHNIQUE. IF MICRO AIR BUBBLES ARE INTRODUCED DURING THE FILLING PROCESS, THEN THE BUBBLES CANNOT BE PURGED DURING PRIMING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL INSPECTION NOTED THAT FLOW WAS NOT OBSERVED AT THE DISTAL LUER. FORCED PRIME WAS ATTEMPTED BUT FLOW WAS STILL NOT OBSERVED. MICROSCOPIC INSPECTION DETERMINED THE CAUSE OF THE NO-FLOW CONDITION TO BE MICROSCOPIC AIR BUBBLES BLOCKING THE LUMEN OF THE GLASS CAPILLARY LOCATED INSIDE THE FLUID RESTRICTOR. NO DEVICE MALFUNCTION WAS DETECTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD DID NOT FULLY DELIVER DURING PATIENT USE. ONLY 6 ML OF SOLUTION WAS INFUSED INTO THE PATIENT AFTER 3 HOURS OF INFUSION. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127228 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12D032

    Patients

    Seq Age Sex Outcome Treatment
    1 LASIX