BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3240900 · Received July 17, 2013

    Report

    Report Number
    1314492-2013-01349
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. EVAL CONFIRMED A FLOW RATE INACCURACY BELOW SPECIFICATION AT THE RATE OF 40 ML/HR. THE DEVICE PASSED FLOW RATE TESTING PER THE SPECTRUM PREVENTATIVE MAINTENANCE PROCEDURE, AS WELL AS ADDITIONAL FLOW RATE TESTING. EVAL FOUND THE VALVE TRAVEL AND FINGER TRAVEL TO BE OUT OF SPECIFICATION. THE DEVICE PASSED UPSTREAM AND DOWNSTREAM OCCLUSION TESTING PER THE SPECTRUM SERVICE MANUAL (PM INSPECTION), AS WELL AS ADDITIONAL OCCLUSION TESTING. THE DEVICE WAS DETERMINED TO NOT BE OPERATING WITHIN SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM. THE VALVE AND FINGER TRAVEL WAS REWORKED AND THE DEVICE WAS RECALIBRATED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP'S FLOW RATE WAS INACCURATE. THE CUSTOMER STATED THAT DURING BIOMEDICAL TESTING, THE PUMP UNDER INFUSED AN INFUSION OF NORMAL SALINE (250 CC BAG) RUNNING AT 250 ML/HR WITH A VTBI OF 250 ML. IT WAS REPORTED THAT BETWEEN 10 CC AND 45 CC OF SOLUTION WAS LEFT IN THE BAG. THE CUSTOMER ALSO STATED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332126 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER STANDARD PRIMARY IV SETS| NORMAL SALINE