BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3802940 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14975
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K853881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED SEPTEMBER 19, 2012 ¿ SEPTEMBER 21, 2012. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED. DURING AND AFTER FILL, NO EVIDENCE OF LEAK WAS OBSERVED. 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 LEAKAGE WAS OBSERVED FROM THE BOTTOM OF THE INFUSOR PATIENT CONTROL MODULE WATCH CHAMBER. IT WAS REPORTED THAT THIS OCCURRED DURING FILLING OF THE DEVICE WITH ¿SUFENTAL-290, EMCAINE-20, ROPIVA-10¿ AND NORMAL SALINE FOR A TOTAL FILL VOLUME OF 100 ML. THE REPORTER STATED THAT THE RESERVOIR DID NOT APPEAR TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280463 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12J008

    Patients

    Seq Age Sex Outcome Treatment
    1