BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2684004 · Received July 31, 2012

    Report

    Report Number
    1314492-2012-00168
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EXCESSIVE DRIP AND PRESSURE TESTING WAS CONDUCTED AT 60 DEGREES FAHRENHEIT WITH THE UNIT PASSING. ADDITIONALLY, UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SIGMA PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. THE PROGRAMMED PARAMETERS OF THE REPORTED INACCURATE DELIVERY OF MEDICATION TO A PT ARE CURRENTLY UNK AND SUBSEQUENTLY THE MAGNITUDE OF THE ALLEGED ERROR COULD NOT BE DETERMINED. AT THIS TIME, THE DATE OF EVENT IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP DID NOT DELIVER AN ACCURATE AMOUNT OF MEDICATION TO A PT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY. THE DEVICE WAS TESTED BY THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT TO DELIVER 10ML AT A RATE OF 345ML/HR. THE CUSTOMER STATED THAT THE PUMP ONLY DELIVERED 8ML.

    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