BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEELCRAFT, INC.

    MDR report key: 519300 · Received March 23, 2004

    Report

    Report Number
    MW1031641
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    March 11, 2004
    Report Date
    March 23, 2004
    Manufacturer
    STEELCRAFT, INC.
    Product Code
    FOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR ON 7/1/2004: THE FINAL DETERMINATION OF MFR'S INVESTIGATION ABT0001 REGARDING INFUSION STAND BASES 2006-02 WAS THAT THE CASTER INSERTS WERE OVERSIZED (GREATER THAN MAXIMUM DIMENSION OF 0.454") WHEN THIS WAS INITIALLY DETERMINED MFR IMMEDIATELY HAD A REPRESENTATIVE FROM THE BASE MANUFACTURER GO INTO HOSPITAL TO INSPECT THE BASES AND TO EVALUATE THE SITUATION. UPON INSPECTION THE MFR REPRESENTATIVE CONCURRED THAT THE CAUSE OF THE CASTERS FALLING OUT OF THE BASES WAS DUE TO AN EXCEEDED ID SPECIFICATION ON THE CASTER INSERTS. MFR, AFTER FURTHER INTERNAL INVESTIGATION DETERMINED THAT THE PROGRESSION FEED ON THE DIE THAT MAKES THE BLANK FORM OF THE BASE LEG MAY NOT HAVE BEEN SET UP PROPERLY. THEREFORE A WIDER OPENING ALLOWED THE CASTER TO FORCE THE SEAM OF THE CASTER INSERT TO OPEN UP CAUSING CASTERS TO COME OUT. THE MFR COMPLAINT DEPARTMENT ISSUED A QUERY WITH COMPLAINTS AGAINST 2006-02 FOR THE TIME PERIOD 01/01/2000 TO 03/12/2004. THE REPORT FOUND THAT 6 ADDITIONAL CUSTOMERS (OTHER THAN HOSPITAL) WITH SIMILAR COMPLAINT OF WHEELS FALLING OFF THE BASE AND ALL INCIDENTS WERE DURING PRE-INSTALLATION OF THE I.V. STAND. THESE COMPLAINTS EXCEPT ONE DATED 06/06/2003, WERE FROM THE 4TH QUARTER OF 2003 AND THE 1ST QUARTER OF 2004. REPLACEMENT UNITS WERE SENT TO THESE ADDITIONAL CUSTOMERS AND NO FURTHER ACTIONS WERE REQUIRED. WITH THE EXCEPTION OF TWO COMPLAINTS FROM HOSPITAL, THE PROBLEM WAS IDENTIFIED DURING THE RECEIPT AND INSTALLATION OF STAND BASES AND THUS THEY WERE NOT PUT INTO SERVICE. THE OVERALL IMPACT WAS DETERMINED TO BE LOW BASED ON THE PROBABILITY OF THIS ISSUE BEING IDENTIFIED DURING INSTALLATION. A CORRECTIVE ACTION HAS BEEN ISSUED BY MFR TO MOVE TO A SOLID TUBE FOR THE CASTER INSERT RATHER THAN THE WELDED TUBE. THUS THE CASTER INSERT WILL ALWAYS RETAIN ITS ID. IN ADDITION THIS INSERTS ID HAS BEEN REDUCED FROM .450 +/- .004 TO .446 +/- .002. THIS REDUCTION ACHIEVED AN INCREASE IN LBS OF PRESSURE REQUIRED TO REMOVE THE CASTER WITH A PULL TEST FROM AN AVERAGE OF 20 LBS TO AN AVERAGE OVER 60 LBS. (THE SPECIFICATIONS REQUIRES A PULL TEST OF OVER 8 LBS). MFR CONTINUES TO CHECK THE ID OF ALL BASES WITH A NOGO GAUGE AS WELL AS TO PERFORM PULL TESTS ONCE THE CASTERS ARE INSERTED INTO THE BASES. AS OF NOW ALL BASES DISTRIBUTED BY MFR WILL INCLUDE THIS CORRECTIVE ACTION.

    Description of Event or Problem · 1

    NEW IV PUMPS BEING PULLED OUT OF SERVICE FOR RE-TOOLING. HOLES ARE BIGGER THAN SPROCKET. POLES EASILY PULL OUT OF BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEELCRAFT, INC. IV POLES FOX STEELCRAFT, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other ALL 380 POLES BEING RETURNED FOR RETOOLING.| ALL 380 POLES BEING RETURNED FOR RETOOLING.