BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3060561 · Received March 27, 2013

    Report

    Report Number
    1314492-2013-00304
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO: (B)(4). BAXTER IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP ALARMED FOR "UPSTREAM OCCLUSION!" WHEN NO UPSTREAM OCCLUSION WAS PRESENT. THE ALARM OCCURRED IN THE SICU DURING AN INFUSION OF VANCOMYCIN AT A RATE OF 170 ML/HR. IT WAS REPORTED THAT MICROBUBBLES WERE OBSERVED IN THE TUBING. IT WAS ALSO REPORTED THAT THE TEMP OF THE SOLUTION WAS INITIALLY COLD. THE CUSTOMER WAS USING TUBING (PICC LINE) WITH NO SLACK, WITH 6" HEAD HEIGHT, AND CLAMPED 6"-8" BELOW THE Y-SITE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124959 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1