BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3063149 · Received February 27, 2013

    Report

    Report Number
    1314492-2013-00162
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. KNOWN CONDITIONS RESULTING IN FLOW FROM THE PRIMARY CONTAINER DURING A SECONDARY INFUSION SEGMENT INCLUDE AN INADEQUATE HEIGHT DIFFERENTIAL BETWEEN THE PRIMARY AND THE SECONDARY IV CONTAINERS, OR A HIGH FLOW RATE (TYPICALLY ABOVE 300 ML/HR). THE SPECTRUM OPERATORS MANUAL RECOMMENDS THE PRIMARY IV CONTAINER BE PLACED 20 INCHES BELOW THE SECONDARY IV CONTAINER TO PROVIDE A GRAVITY ADVANTAGE THAT ALLOWS FLOW FROM THE SECONDARY IV CONTAINER ONLY, AND WARNS THE USER OF THE POSSIBILITY OF PRIMARY IV CONTAINER SIPHONING WITH FLOW RATES ABOVE 300 ML/HR. BAXTER IS ACTIVELY WORKING WITH THE CUSTOMER TO MITIGATE RELATED CONCERNS.

    Description of Event or Problem · 1

    A PRIMARY INFUSION OF 250ML AND A SECONDARY INFUSION OF 100ML WERE PROGRAMMED (MEDICATION AND DELIVERY RATE UNK). IT WAS REPORTED THAT DURING THE PUMP CONTROLLED SECONDARY INFUSION, THE DEVICE DID NOT DELIVER THE SECONDARY MEDICATION. THE CUSTOMER STATED THAT THE IV SET WAS DISCONNECTED AND THE INJECTION SITE WAS "SWABBED." WHEN THE INFUSION WAS RESTARTED, SIMULTANEOUS FLOW FROM THE PRIMARY AND SECONDARY CONTAINERS WAS OBSERVED. THE IV SITE WAS "SWABBED" AGAIN, AND THE SECONDARY INFUSION WAS THEN DELIVERED AS PROGRAMMED. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84545 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER IV SET (B)(4)| 3 CLEARLINK Y-SITES| CONTINU-FLO SOLUTION SET WITH DUO-VENT SPIKE, 105"| 10 GTT DEHP| (B)(4)