BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 2042414 · Received April 6, 2011

    Report

    Report Number
    1314492-2011-00011
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVAL INDICATES A LOWER BEARING FAILURE OCCURRED. A F/U REPORT WILL BE SUBMITTED, ONCE A FULL EVAL HAS BEEN CONDUCTED BY SIGMA ENGINEERING.

    Description of Event or Problem · 1

    FAILED FLOW RATE TEST HIGH, RATE 200, VTBI 50, WHEN VOLUME GIVEN INDICATED 10 ML HAD INFUSED THE GRADUATE ALREADY HAD COLLECTED 18 ML. PUMP WAS THEN PUT INTO THE IN-STOP MODE WHERE IT WAS FOUND TO BE FREE FLOWING. THE SYMPTOM WAS DISCOVERED DURING A ROUTINE INSPECTION. CLINICAL ENGINEERING ADDED THAT THEIR FIRST FINDING WAS THAT THE PUMP FAILED THE FLOW RATE TESTS LOW, RATE 400, VTBI 40, DELIVERED 35 ML. CLINICAL ENGINEERING REPORTED THAT THERE WAS NOT ANY INACCURACY OR INCIDENT REPORT FROM NURSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 732239

    Patients

    Seq Age Sex Outcome Treatment
    1