BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 6639914 · Received June 14, 2017

    Report

    Report Number
    1416980-2017-05012
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Report Date
    July 12, 2017
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    PMA / PMN Number
    K051253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DATE: AUGUST 20, 2016 ¿ AUGUST 21, 2016. TWO DEVICES WERE RETURNED WITH EACH UNIT CONTAINING APPROXIMATELY 120 AND 300ML OF SOLUTION IN THE BLADDER. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. VISUAL INSPECTION WAS PERFORMED AND NOTED THE UNITS WERE WET, HOWEVER THE SOURCE OF THE WETNESS COULD NOT BE IDENTIFIED. A FUNCTIONAL LEAK TEST WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK WAS OBSERVED FROM TWO (2) REGIONAL ANALGESIA INFUSORS WITH PCM 5-7-12 ML/H. THE LEAKS WERE OBSERVED DURING DELIVERY IN THE RESPECTIVE PLANT. THE INFUSORS CONTAINED FENTANILE 0.5 MG/ML, BUPIVACAINE 5MG/ML, ADRENALINE 1 MG/ML, NACL. THE INCIDENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422200 INFUSOR PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE NA 16H039

    Patients

    Seq Age Sex Outcome Treatment
    1