BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 8002+

    MDR report key: 847080 · Received April 5, 2007

    Report

    Report Number
    1314492-2007-00008
    Event Type
    Other
    Date Received
    April 5, 2007
    Date of Event
    January 23, 2007
    Report Date
    February 28, 2007
    Manufacturer
    SIGMA INTL.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    SIGMA INTERNATIONAL INVESTIGATED THE APPEARANCE OF CRACKS ONTO MODEL 8002 PUMP BODY AND ISSUED AN ENGINEERING REPORT IN 2007. ER8002-028 DETAILED THE INSTRUCTIONS TO FIX THIS PROBLEM AND VALIDATED THE RESULTS OF THE REPAIR. ALL PUMPS REPAIRED ACCORDING TO THIS METHOD PASSED THE VALIDATION TEST. SUBSEQUENTLY, "PUMPING MECHANISM MAINTENANCE, SIGMA INTERNAL REPAIR PROCEDURE, SIGMA MODEL 8002 IV PUMP" AND "PUMPING MECHANISM MAINTENANCE IN THE FIELD, SIGMA MODEL 8002 IV PUMP" WERE APPROVED AND RELEASED FOR USE. THE OCCURRENCE OF CRACKS HAS BEEN TRENDED AND RESULTS SHOWED THAT A FREQUENT CAUSE OF THIS ISSUE IS EITHER IMPLACT OR CLEANING FLUID MISUSE. THE OPERATOR'S MANUAL CLEARLY STATES APPROPRIATE CLEANING METHODS AND APPROVED FLUIDS. IT ALSO CAUTIONS AGAINST USE FOLLOWING AN IMPACT.

    Description of Event or Problem · 1

    AFTER DISCOVERING A FREE-FLOW PROBLEM WITH A SIGMA INFUSION PUMP ON A PT AT MED CTR, NURSING ADMIN AND BIOMEDICAL STAFF BEGAN TO INSPECT EVERY SIGMA 8002+ DUAL CHANNEL INFUSION PUMP IN THE FACILITY FOR CRACKS. THE FREE-FLOW REPORTED THAT OCCURRED WAS NOT THE 1ST FREE-FLOW INCIDENT WITH THE SIGMA DUAL CHANNEL PUMPS, IT WAS THE 2ND. THE 1ST, AS REPORTED TO THE FDA HAD OCCURRED IN 2006. TWO MORE PUMPS HAD BEEN DISCOVERED WITH CRACKS IN THE TUBING CHANNEL, AN AREA WHEREIN STRUCTURAL INTEGRITY IS CRITICAL TO THE SAFE OPERATION OF THESE PUMPS. I TOOK SEVERAL PUMPS APART AND COMPARED THE DESIGN TO THAT OF THE NEARLY IDENTICAL SINGLE CHANNEL 8000+ MFG BY SIGMA. A STARTLING DIFFERENCE WAS NOTED. IN AN AREA OF A PLASTIC CASING, WHERE STRENGTH IS CRITICAL, A HOLE HAD BEEN DRILLED TO ACCOMODATE AN ASSEMBLY SCREW. THIS HOLE HAS A BRASS THREADED INSERT PRESSED INTO PLACE TO ACCEPT THE ASSEMBLY SCREW. IN MY OPINION, THIS HOLE AND THE PRESSED-IN INSERT GREATLY WEAKENS THE STRUCTURE OF THIS AREA, AN AREA THAT THE PUMPING MECHANISM ACTS AGAINST WHEN DELIVERING THE INFUSED MED. THIS HOLE IS NOT ON THE SINGLE CHANNEL INFUSION PUMP OF THE SAME MODEL TYPE BY THE SAME MFG. ALL CRACKS THAT HAVE BEEN DISCOVERED ON THESE PUMPS AT THIS FACILITY, ALL CENTER AROUND 1 OF THESE 2 HOLES/BRASS INSERTS. THE FRONT OF THE ASSEMBLY THAT CONTAINS THESE QUESTIONABLE HOLES PROTRUDES FROM THE FRONT OF THE PUMP, OFFERING A SURFACE EASILY IMPACTED WHEN MOVING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 8002+ GENERAL PURPOSE INFUSION PUMP FRN SIGMA INTL. 8002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *