BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2944298 · Received January 11, 2013

    Report

    Report Number
    1314492-2013-00022
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER EVALUATED THE DEVICE IN QUESTION. A FLOW RATE TEST WAS PERFORMED PER THE BAXTER PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE DEVICE ALSO PASSED ADDITIONAL FLOW RATE TESTS. ADDITIONALLY, UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE BAXTER PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. A REVIEW OF THE HISTORY LOG SHOWS A DOOR JAMMED! AND SET IMPROPERLY LOADED! ALARM THAT WAS CORRECTED JUST PRIOR TO THE START OF THE INFUSION. THE HISTORY LOG SHOWS THE INFUSION RAN PROPERLY WITH NO OTHER ALARMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO DELIVER A PRIMARY INFUSION OF NORMAL SALINE AT A RATE OF 150ML/HR, VTBI 900ML. THE CUSTOMER STATED THAT AT THE START OF THE INFUSION, THE IV BAG CONTAINED 1000ML; IT WAS OBSERVED THAT FOUR HOURS INTO THE INFUSION, THE IV BAG CONTAINED 950ML. THE CUSTOMER ALSO STATED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19331 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1