BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2114251 · Received June 4, 2011

    Report

    Report Number
    1314492-2011-00021
    Event Type
    Other
    Date Received
    June 4, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PUMP OR SERIAL NUMBER WAS PROVIDED AND NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. HOWEVER, THERE IS CURRENTLY INSUFFICIENT INFORMATION TO CONCLUDE A DEVICE MALFUNCTION OCCURRED, AND THE IV ADMINISTRATION SET REFERENCED IN THE REPORT TO SIGMA IS NOT A SIGMA PRODUCT. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS REPORTED TO SIGMA BY A DISTRIBUTOR SALES REPRESENTATIVE FOR AN "INCIDENT" INVOLVING A SIGMA SPECTRUM LARGE VOLUME INFUSION PUMP. "THE NURSE HOOKED UP THE HUBER NEEDLE TO THE PORT AND GOT A GOOD BLOOD RETURN. SHE HOOKED UP THE RYMED INVISION PLUS. HOOKED UP THE 2C8537 AND THE 250 SALINE BAG RUNNING THROUGH THE PUMP. THE PUMP INDICATED A DOWN STREAM OCCLUSION, ONCE THE PUMP SHOWED AN OCCLUSION, IT STOPS, THEN, WHEN THE PUMP SHOWED NO OCCLUSION, THE PUMP AUTOMATICALLY STARTED UP AGAIN, AND OCCLUDED AGAIN. THE NURSE SAID THAT SHE WENT TO DISCONNECT THE RYMED VALVE AND RECONNECT TO SEE IF THAT WORKED TO STOP THE OCCLUSION AND SHE WAS SPRAYED IN THE FACE, EYES AND MOUTH WITH THE SALINE FROM DISCONNECTING THE 2C8537. THERE WAS NO MENTION OF LEVEL OF PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION IN REGARDS TO THIS REPORT. NO FURTHER INFORMATION WAS GIVEN ABOUT THE NURSE'S CONDITION." THE DATE OF THE EVENT IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1