BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA MODEL SPECTRUM

    MDR report key: 2112298 · Received April 29, 2011

    Report

    Report Number
    1314492-2011-00013
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SIGMA RECEIVED A CORRESPONDENCE FROM THE BIOMEDICAL TECHNICIAN AT MADISON MEMORIAL HOSPITAL ON (B)(6), 2011. HIS ANALYSIS FOUND THE PUMP PASSING ALL TESTING INCLUDING KEYBOARD, UPSTREAM OCCLUSION SENSOR, DOWNSTREAM OCCLUSION SENSOR, MEMORY AND FLOW RATE ACCURACY. HE WAS UNABLE TO COMPLETE THE BATTERY CAPACITY TEST DUE TO AN ERROR CODE 601. SIGMA EVALUATED THE RETURNED PUMP ON (B)(6) 2011 AND WAS ABLE TO CONFIRM THE ERROR CODE 601. THIS ERROR CODE INDICATES "SHARP SOFTWARE CORRUPTION." THIS CAN BE CAUSED BY PSEUDO SINGLE BIT CHARGE LOSS WHICH OCCURS IF THERE IS A FLASH MEMORY READ ERROR. THE CHIP MANUFACTURER (SIGMA SUPPLIER) ESTIMATED THE RATE OF THIS INCIDENT OCCURRING IN A FLASH CHIP IS APPROXIMATELY 6.7 PPM. SIGMA HAS SUBSEQUENTLY MITIGATED THIS POTENTIAL FAILURE MODE WITH THE RELEASE OF V6.02.02 SOFTWARE. THIS SOFTWARE VERSION IMPLEMENTED A DOUBLE-PASS PROGRAMMING ALGORITHM TO REDUCE THIS POTENTIAL FAILURE MODE. SIGMA CONCLUDED THAT THE DEVICE ACCURATELY IDENTIFIED THE FAILURE MODE BY PROVIDING THE CLINICIAN WITH THE PROPER ERROR CODE (601). THERE WAS NO REPORTED PATIENT HARM OR MEDICAL INTERVENTION INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO SIGMA AS FOLLOWS: "NURSE REPORTED PUMP READ OUT ERROR CODE 601 AND STOPPED DURING AN INFUSION AND SHE CHANGED PUMPS TO CONTINUE INFUSING THE PATIENT. DURING TEST RUN, PUMP REPEATED SAME ERROR CODE ON TEST BENCH. HAS ALSO GIVEN ERROR 322 LOWER LINK SWITCH ERROR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA MODEL SPECTRUM SPECTRUM INFUSION PUMP FRN SIGMA LLC 35700 732175

    Patients

    Seq Age Sex Outcome Treatment
    1