BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA

    MDR report key: 819188 · Received February 8, 2007

    Report

    Report Number
    MW1041934
    Event Type
    Other
    Date Received
    February 8, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 8, 2007
    Manufacturer
    SIGMA INTERNATIONAL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 29, A SIGMA 8002 PLUS DUAL-CHANNEL INFUSION WAS DELIVERED TO THE BIOMEDICAL ENGINEERING DEPT AT MED CTR WITH A RED TAG AFFIXED TO IT. THE TAG READ "DO NOT PLACE BACK INTO CIRCULATION. SIDE B INFUSED 1 LITER OF FLUID OVER 1 1/2 HOURS EVEN THOUGH IT WAS PROGRAMMED FOR 75 ML/HR." THIS WAS FOLLOWED BY AN INCIDENT REPORT WITH FURTHER DETAIL. SPECIFICALLY, NO MEDICATION WAS USED, ONLY A SALINE BAG, NO ADVERSE PT REACTION, NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT. THE PUMP WAS DISCOVERED WITH THE EMPTY BAG BY THE NURSE AS A RESULT OF THE PUMP ALARMING CAUSED BY AIR IN THE IV LINE. THERE WERE NO IMMEDIATE VISIBLE INDICATIONS THAT THIS PUMP HAS BEEN STRUCK OR DROPPED OR OTHERWISE PHYSICIALLY DAMAGED. AFTER A THOROUGH INSPECTION, ONLY ONE VERY SMALL INDICATION OF A POSSIBLE IMPACT WAS NOTICED: THE FRONT AND BACK PUMP HOUSING MATING SURFACE WAS VERY SLIGHTLY SPLAYED OUTWARD ON THE RIGHT "B" SIDE. DURING THIS INSPECTION IT WAS NOTED THAT THERE WAS AN UNCHARACTERISTIC RATTLE INSIDE THE PUMP. UPON OPENING THE PUMP UP -SEPARATING THE FRONT AND BACK HALF OF THE OUTER CASE- A SMALL PIECE OF THE CASING WAS FOUND TO HAVE BROKEN OFF. THIS PIECE WAS ONE OF THE FLANGES THAT RECEIVES ONE OF THE FOUR ASSEMBLY SCREWS HOLDING THE FRONT AND BACK HALVES OF THE PUMP TOGETHER. FURTHER INSPECTION REVEALED THAT SOME INTERNAL COMPONENTS ON THE "B" SIDE WERE LOOSE. THIS COMPONENT IS PART OF THE ACTUAL PUMPING MECHANISM. WHEN THE PUMP WAS LOOKED AT AGAIN FROM THE FRONT, THE HOUSING CRACK INSIDE THE TUBING CHANNEL WAS APPARENT AND WAS THE CAUSE OF THE LOOSE COMPONENTS. THESE COMPONENTS BEING LOOSE WOULD NOT ALLOW THE PUMPING MECHANISM TO HOLD FIRM AGAINST THE OPPOSING SIDE WHEREIN THE IV TUBING IS COMPRESSED DURING OPERATION. WITHOUT THAT FIRM SUPPORT, THE TUBING CAN, AND APPARENTLY DID FREE FLOW. SUCH A CRACK IN THE CASING IS ONLY VISIBLE WHEN THE TUBING CHANNEL IS INSPECTED BY SOMEONE WHO HAS EXPERIENCE WITH THESE PUMPS AND KNOWS WHAT TO LOOK FOR. MEDICAL CTR HAS HAD THE SAME CRACK IN AN IDENTICAL PUMP IN 08/06. SPECULATING WHAT HAD CAUSED THE CRACK, IT WOULD SEEM THAT THE PUMP HAD BEEN DROPPED OR STRUCK, ALTHOUGH AS MENTIONED ABOVE, THERE WAS VIRTUALLY NO INDICATION THAT SUCH HAD HAPPENED. THIS PUMP HAD NO ERRORS OR ALARMS THAT ALERTED THE USER THAT THE PHYSICAL INTEGRITY UPON WHICH PROPER PUMP ACTION DEPENDS, WAS COMPROMISED. THE MANUFACTURER, SIGMA, HAD BEEN NOTIFIED OF THE INCIDENT AND ONCE AUTHORIZED BY MANAGEMENT FOR TRANSFER, THE PUMP WILL BE RETURNED TO THE MFR FOR EVALUATION AND REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other