BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORBIT INFUSION SET

    MDR report key: 2040164 · Received March 21, 2011

    Report

    Report Number
    2025816-2010-00127
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    October 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A TWO YR REVIEW OF THE COMPLAINT DATABASE FOR SAME/SIMILAR REPORTS WAS PERFORMED. THE RESULTS DID RECORD ADDITIONAL REPORTS AND INVESTIGATIONS. DEVICE RETURNED AGAINST THOSE REPORTS DOCUMENT MIXED FINDINGS (CONFIRMED AND NO DEFECT FOUND). ALTHOUGH, THE COMPLAINT RATE WAS STATISTICALLY INSIGNIFICANT (.001664% DEFECT RATE) A SLIGHT TREND WAS IDENTIFIED. ENGINEERING ANALYSIS FOUND THAT THE COMPONENT DAMAGES MOST LIKELY OCCURRED DURING FINAL PACKAGING AND/OR TRANSIT. IMPROVEMENTS WERE MADE TO BOTH THE ORBIT NEEDLE SHEATH COMPONENT AND ORBIT BLISTER PACKAGING TO ADDRESS THESE ISSUES. SINCE COMPONENT/PACKAGING ADJUSTMENTS AND ENHANCEMENTS WERE IMPLEMENTED THERE HAVE BEEN NO REPORTS FROM POST-FIX LOTS OF THIS COMPONENT/PACKAGING ISSUE. ADDITIONAL REMEDIAL ACTIONS: USE OF MEDICAL DEVICES THAT HAVE BEEN DAMAGED/COMPROMISED IS CONTRAINDICATED. THIS WAS IMMEDIATELY COMMUNICATED DIRECTLY TO THE CONSUMER AND TO THEIR HEALTHCARE PROVIDER (INSULINPUMP.CA). CONCLUSION: THE INVOLVED ORBIT DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE REPORTED PRODUCT PROBLEM (OCCLUSION/FLOW ISSUES) WERE MOST LIKELY CAUSED DURING USE OF ORBIT DEVICES WHERE THE NEEDLE COMPONENTS WERE BENT/DAMAGED AND MODIFIED OR "SELF REPAIRED".

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING ON-GOING, INTERMITTENT ISSUES WITH USE OF P3051 ORBIT DEVICES WHERE NEEDLE COVERS WERE LOOSE OR MISSING; NEEDLES WERE BENT/DAMAGED AND OCCLUSION ISSUES WHEN USED WITH ACCU-CHEK SPIRIT INSULIN PUMPS. IN EACH OF THE EVENTS, THE ORBIT SETS DAMAGED NEEDLE COMPONENTS WERE VISUALLY DETECTED WHILE STILL IN THE PACKAGING. AFTER OPENING THE PACKAGES WITH BEND NEEDLES, THE DEVICE USER WOULD "STRAIGHTEN THE NEEDLE", SUCCESSFULLY INSERT AND USE THE ORBIT INFUSION SET WITH THE ACCU-CHEK SPIRIT INSULIN PUMPS MAINTAINING ACCEPTABLE BLOOD GLUCOSE CONTROL. ON (B)(6) 2010, IT WAS REPORTED THAT WITH INITIAL CHANGE OUT "...THE NEW SET HAD LOST ITS NEEDLE COVER IN THE PACKAGE AND THE NEEDLE WAS QUITE SERIOUSLY BENT... STRAIGHTENED THE NEEDLE AND INSERTED THE SET..." AFTER AN UNDISCLOSED PERIOD OF TIME USER ".... RECEIVED AN OCCLUSION ALARM ON MY INSULIN PUMP... HAD TO CHANGE THE INFUSION SET... BUT THE SPARE INFUSION SET... WAS ALSO BENT IN THE PACKAGING... AGAIN STRAIGHTENED THE NEEDLE AND INSERTED NEW INFUSION SET... LATER... ABOUT ONE HR AFTER EATING A MEAL AND TAKING MY INSULIN MEAL BOLUS... OCCLUSION ALARM INDICATING THAT NOT ALL OF MY MEAL BOLUS HAD BEEN DELIVERED...ANOTHER CHANGE OF INFUSION SET, THIS TIME ONE THAT DID NOT HAVE A BENT NEEDLE ALLOWED ME TO CORRECT THE HIGH BLOOD GLUCOSE LEVEL..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIT INFUSION SET INFUSION SET FPA ICU MEDICAL, INC. P3051 1660581; UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCU-CHEK SPIRIT INSULIN PUMPS.