BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3539806 · Received December 27, 2013

    Report

    Report Number
    1416980-2013-35766
    Event Type
    Malfunction
    Date Received
    December 27, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM 07/24/2013 TO 07/25/2013. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION FILLED AND WITH A PATIENT CONTROL MODULE (PCM) ATTACHED. VISUAL INSPECTION DID NOT IDENTIFY ANY ISSUES THAT COULD HAVE CAUSED THE REPORTED PROBLEM. FUNCTIONAL FLOW RATE TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS NOT CONFIRMED; NO SIGNS OF FLOW PROBLEMS WERE OBSERVED AND FLOW CONTINUED WITHOUT STOPPING. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BASAL/BOLUS INFUSOR WOULD NOT FLOW. THE REPORTER STATED NO FLOW WAS OBSERVED ¿DUE TO AIR LOCK.¿ THIS OCCURRED DURING FILLING WITH AN UNKNOWN DRUG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677891 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13G053

    Patients

    Seq Age Sex Outcome Treatment
    1