BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2696791 · Received August 9, 2012

    Report

    Report Number
    1314492-2012-00198
    Event Type
    Injury
    Date Received
    August 9, 2012
    Report Date
    July 11, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIGMA'S COMPLAINT EVAL WAS UNABLE TO OBTAIN INFO TO CLARIFY THE REPORTED "IV FILTRATION ISSUE." THE SIGMA SPECTRUM INFUSION PUMP DOES NOT HAVE THE CAPABILITY TO DETECT INFILTRATION EVENTS, WHICH IS COMMUNICATED IN THE SIGMA SPECTRUM OPERATIONS MANUAL AS "THE PUMP WAS NOT DESIGNED NOR IS INTENDED TO DETECT INFILTRATIONS OR EXTRAVASATIONS." SIGMA EVALUATED THE DEVICE IN QUESTION AND A FLOW RATE TEST WAS PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE AND THE DEVICE WAS FOUND TO DELIVER WITHIN SPECIFICATION. ADDITIONALLY, UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SIGMA PREVENTATIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD AN "IV FILTRATION ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA LLC 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other