BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 11309196 · Received February 10, 2021

    Report

    Report Number
    1314492-2021-00310
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Report Date
    February 10, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT VERIFIED. THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION DURING FLOW TESTING. TROUBLESHOOTING THE DEVICE REVEALED NO HARDWARE/SOFTWARE ABNORMALITIES THAT WOULD INDUCE THE REPORTED ALLEGATION. NO CORRECTION IS REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD AN INACCURATE INFUSION DELIVERY. THE PUMP UNDERWENT VOLUMETRIC TESTS WITH THE RATE AT 200 ML/HOUR AND THE VOLUME TO BE INFUSED (VTBI) AT 50 ML. THE ACTUAL AMOUNT DELIVERED WAS NOT PROVIDED, HOWEVER. A PYREX VISTA 70024-50 CYLINDER WAS USED TO MEASURE. AN INTERLINK SYSTEM SOLUTION SET WAS USED AND IT WAS THE 4TH TIME THIS WAS USED. THERE WAS NO KNOWN PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204263 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1