BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4243927 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39932
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT 14A024 WAS MANUFACTURED JANUARY 14, 2014 TO JANUARY 15, 2014. THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION AGAINST THE REPORTED CONDITION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE DEVICE. VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY SIGNS OF BLOCKAGE OR PHYSICAL ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE BY REMOVING THE LUER CAP FROM THE UNIT¿S DISTAL LUER. AFTER THE CAP WAS REMOVED, THERE WAS EVIDENCE OF CONTINUOUS FLOW THAT WAS VISUALLY OBSERVED AT THE DISTAL LUER. BASED ON THE EVALUATION RESULTS, THE REPORTED CONDITION WAS NOT VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE IDENTIFIED WITH THE PROVIDED INFORMATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR UNDERINFUSED. THE REPORTER STATED THAT THE EXPECTED THERAPY TIME WAS 46 HOURS, BUT AFTER TWO DAYS ¿ALMOST ALL MEDICATION¿ REMAINED WITHIN THE DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725546 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A024

    Patients

    Seq Age Sex Outcome Treatment
    1