BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3060563 · Received March 27, 2013

    Report

    Report Number
    1314492-2013-00303
    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

    (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 PHENYLEPHRINE AT A RATE OF 9.1 ML/HR. MICROBUBBLES WERE REPORTEDLY OBSERVED IN THE TUBING. IT WAS ALSO REPORTED THAT THE TEMPERATURE OF THE SOLUTION WAS INITIALLY COLD AND HUNG AT ROOM TEMPERATURE FOR LESS THAN ONE HOUR. IT WAS REPORTED THAT THE PUMP WAS ON A MEDIUM PRESSURE SETTING. THE CUSTOMER WAS REPORTEDLY USING "12" TUBING ((B)(4)) BETWEEN THE PUMP AND THE DRIP CHAMBER, 4" BELOW THE UPPER Y-SITE, WITH A PICC WHICH HAD A 1.2- 3/4 FULL DRIP. FURTHERMORE, IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127121 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) PRIMARY IV SET TUBING