BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2565790 · Received April 26, 2012

    Report

    Report Number
    2565790
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 26, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD PLATELETS TO BE INFUSED. PLATELETS NOTICEABLY DRIPPING AND INFUSING CORRECTLY, HOWEVER WHEN RECHECKED IN APPROX 15 MINUTES PLATELETS FOUND TO BE NOT DRIPPING BUT PUMP WAS STILL RUNNING AS IF PLATELETS WERE INFUSING PROPERLY. AFTER CHECKING TUBING AND REPROGRAMMING PUMP INFUSION STARTED TO RUN PROPERLY AGAIN. HOWEVER WHEN RECHECKED IT WAS FOUND THAT THE SECONDARY BAG WAS BACKED UP INTO THE PLATELETS. PLATELETS WERE CHANGED OFF PUMP INTO DIFFERENT PUMP WITH NO DIFFICULTIES. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA SPECTRUM *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR