BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221515 · Received July 3, 2013

    Report

    Report Number
    1314492-2013-01000
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT IDENTIFIED AND NOT RETURNED TO BAXTER FOR EVAL. IF THE DEVICE IS IDENTIFIED AND RETURNED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD HEIGHT REQUIRED TO MITIGATE NUISANCE ALARMS DURING SECONDARY INFUSIONS IS LOGISTICALLY DIFFICULT TO EXECUTE AT THE FACILITY, PARTICULARLY IN THE BURN UNIT, IN WHICH MULTIPLE PUMPS NEED TO BE ON ONE POLE DUE TO SPECIAL CONSTRAINTS. THE CUSTOMER STATED THAT THE IV BAGS ARE DIFFICULT TO REACH. THE CUSTOMER ALSO STATED THAT THE FACILITY UNDERSTANDS THIS SET-UP PROCESS IS NECESSARY FOR PROPER FUNCTIONALITY OF THE PUMP, AND THAT THERE HAS BEEN NO PT INJURY AS A RESULT OF THE LOGISTICAL DIFFICULTIES IN EXECUTING PROPER HEAD HEIGHT REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303614 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 IV SOLUTION BAGS