BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA

    MDR report key: 757954 · Received September 5, 2006

    Report

    Report Number
    MW1040317
    Event Type
    Malfunction
    Date Received
    September 5, 2006
    Date of Event
    August 29, 2006
    Report Date
    September 5, 2006
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON AUGUST 29, A SIGMA 8002P INFUSION PUMP WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPARTMENT AT SOUTHSIDE REGIONAL MEDICAL CENTER FOR DIAGNOSIS AND REPAIR OF A USER REPORTED PROBLEM. THE REPORTED PROBLEM ON THE OUT OF SERVICE RED TAG WAS AN ERROR CODE, "FIX 23." THE FIX 23 ERROR IS REFERRED TO IN THE SIGMA SERVICE MANUAL AS "LEVER NOT DETECTED IN CLOSED POSITION: IN SECTION 1, PAGE 46. THIS ERROR CODE ON THE FRONT PANEL PRECLUDES THE EQUIPMENT FROM BEING FURTHER USED UNTIL A QUALIFIED TECHNICIAN WITH THE PROPER ACCESS CODES CAN CLEAR THE CODES AND FURTHER INSPECT OR TEST THE DEVICE FOR PROPER OPERATION PRIOR TO PLACING THE UNIT BACK IN SERVICE. THE ONLY PERSONNEL AT HOSP AUTHORIZED TO CLEAR THIS ERROR CODE AND PLACE THE UNIT BACK IN SERVICE IS BIOMEDICAL TECHNICIANS. DURING THE CLEARING OF THE FIX 23 ERROR, THE TECHNICIAN TOOK THE TIME TO CHECK THE FLOW VOLUME AFTER HE NOTICED SOME VERY MINOR DAMAGE TO THE OUTSIDE OF THE CASE ON THE LOWER LEFT CORNER, FRONT, VERY NEAR THE LEVER HINGE. WHILE CHECKING THE FLOW VOLUME, WHEREIN A DOSE VOLUME IS ENTERED ON THE USER PANEL AND THE RESULTANT OUTPUT IS COLLECTED AND MEASURED IN AN APPROPRIATE, GRAUDATED VESSEL, THE PUMP BEGAN TO FREE FLOW, ALLOWING FOR A POTENTIALLY MASSIVE OVER-INFUSION WITH NO DETECTION OF THIS ERROR BY THE EQUIPMENT. UPON FURTHER INSPECTION, THE TECHNICIAN LOOKED INTO THE TUBE CHANNEL WITH A FLASHLIGHT AND NOTICED A CRACK IN THE PUMP HOUSING, ONLY VISIVLE WHEN THE TUBE CLAMP IS RETRACTED AND THE IV SET IS REMOVED. THIS CRACK ALLOWED THE SOLID SURFACE AGAINST WHICH THE TUBE CLAMP ACTS TO FLEX, PERMITTING THE TUBE CLAMP TO OPEN WIDER THAN DESIRED, ALLOWING THE FREE FLOW PROBLEM, EVEN WHEN THE PUMP IS TURNED OFF. THE CRACK APPEARS TO HAVE BEEN THE RESULT OF STRIKE AGAINST THE FRONT OF THE UNIT NEAR THE BASE OF THE CLAMP MECHANISM. ONCE AUTHORIZED FOR TRANSFER BY HOSPITAL MANAGEMENT FOR RECORD KEEPING PURPOSES, THIS PUMP WILL BE RETURNED TO SIGMA WITH A FULL DESCRIPTION OF THIS PROBLEM. IN THE SIGMA SERVICE MANUAL "FIX 23" AS "LEVER NOT DETECTED IN CLOSED POSITION" IN SECTION 1, PAGE 46. IN THAT SECTION, THERE ARE SOME FURTHER CAUTIONS WHEN CLEARING VARIOUS OTHER CODES, BUT THERE ARE NO SPECIFIC CAUTIONS WHEN CLEARING A FIX 23 ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA INFUSION PUMP FRN SIGMA 8002F *

    Patients

    Seq Age Sex Outcome Treatment
    1 *