BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP

    MDR report key: 7061053 · Received November 27, 2017

    Report

    Report Number
    3012307300-2017-02481
    Event Type
    Injury
    Date Received
    November 27, 2017
    Report Date
    March 26, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Removal / Correction Number
    11/21/2017-003-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL REPORTING NUMBER: 3012307300-11/21/2017-003-C. FROM RECALL NOTICE: CONSIGNEES WERE NOTIFIED VIA MAIL ON 11/13/2017, 01/09/2018, AND 02/12/2018, AS A RESULT OF EXPANSIONS OF THE RECALL AND THE NEED TO PROVIDE ADDITIONAL INSTRUCTIONS AND INFORMATION TO CONSIGNEES. INSTRUCTIONS IN THE FIRST LETTER DATE 11/13/2017 INSTRUCTED CUSTOMERS TO ALWAYS CONFIRM THE ACCURACY OF INFUSION VALUES TO THE ORIGINAL ORDER, INCLUDING VERIFYING SYRINGE SIZE, TO UTILIZE THE ENCLOSED REFERENCE TOOL WHEN VERIFYING SYRINGE SIZE, AND TO COMPLETE THE RETURN THE RESPONSE FORM. INSTRUCTIONS IN THE LETTER DATED 01/09/2018 INCLUDED TO ALWAYS CONFIRM THE ACCURACY OF INFUSION VALUES TO THE ORIGINAL ORDER, INCLUDING VERIFYING SYRINGE SIZE, TO ADVISE ALL CLINICIANS OVERSEEING USE OF THE AFFECTED DEVICES TO UTILIZE THE ENCLOSED REFERENCE TOOL, TO REMOVE THE PUMP IF THE SYRINGE IS NOT RECOGNIZED OR IS READ AS AN INCORRECT SIZE DURING PROGRAMMING OR INFUSION, TO NOTIFY IMPACTED CUSTOMERS IF THE DEVICES WERE FURTHER DISTRIBUTED, AND TO COMPLETE THE RETURN THE RESPONSE FORM. INSTRUCTIONS IN THE LETTERS DATED 02/12/2018 INCLUDED TO IDENTIFY ANY AFFECTED DEVICES ON HAND, COMPLETE AND RETURN THE URGENT MEDICAL DEVICE RECALL RESPONSE FORM, AND ARRANGE FOR REPAIR OF THE AFFECTED AS PER THE LOCATION OF THE CONSIGNEE IN CANADA OR THE USA. IF THE CONSIGNEE IS LOCATED IN THE USA, THE THREE OPTIONS INCLUDE TO RETURN TO SMITHS MEDICAL FOR REPAIR, ARRANGE FOR THE SHIPMENT OF THE REQUIRED PARTS AND HAVE THE CONSIGNEE'S ONSITE BIOMED TEAM COMPLETE THE REPAIR, OR ARRANGE FOR ONSITE REPAIR BY SMITHS MEDICAL IF THERE ARE MORE THAN 10 PUMPS ONSITE. IF THE CONSIGNEE IS LOCATED IN (B)(6), THE TWO OPTIONS INCLUDE TO RETURN TO SMITHS MEDICAL FOR REPAIR OR ARRANGE FOR THE SHIPMENT OF THE REQUIRED PARTS AND HAVE THE CONSIGNEE'S ONSITE BIOMED TEAM COMPLETE THE REPAIR. CONSIGNEES NOT LOCATED IN THE USA OR CANADA WERE INSTRUCTED TO CONTACT THEIR SMITHS MEDICAL REPRESENTATIVE TO DISCUSS REPAIR OPTIONS. INVESTIGATION: THE RETENTION SPRING WITHIN THE BARREL CLAMP MECHANISM WAS FOUND TO HAVE SLIPPED OUT OF PLACE. THE FUNCTION OF THIS SPRING IS TO PROVIDE THE CLAMPING FORCE FOR THE BARREL CLAMP MECHANISM. ONE END OF THIS SPRING IS INTENDED TO BE RETAINED BY A SHOULDER ON THE BARREL CLAMP ROD; HOWEVER, IN THIS CASE, THE SPRING HAD SLIPPED OVER THE SHOULDER. IT WAS FOUND THAT RETENTION SPRING CAUSED INTERFERENCE WITH THE BARREL CLAMP SLIDE, WHICH CONNECTS TO THE POTENTIOMETER. THIS INTERFERENCE CAUSES THE CALIBRATION OF THE MEASUREMENT FUNCTION TO BE AFFECTED, SUCH THAT IT CAN NO LONGER ACCURATELY IDENTIFY THE SIZE OF THE SYRINGE. FURTHER INVESTIGATION DETERMINED THAT THIS SLIPPAGE OF THE RETENTION SPRING IS ASSOCIATED WITH BARREL CLAMP GUIDES, WHICH HAVE SINCE BEEN REWORKED. THE REWORK, WHICH OCCURRED AT THE SUPPLIER AND SMITHS MEDICAL, REMOVED A RIDGE IN THE MOLDED PART CAUSED BY A MIS-ORIENTED EJECTOR PIN, WHICH EJECTS THE GUIDE FROM THE MOLD. OCCURRENCE OF SLIPPAGE IN THE RETENTION SPRING MAY CAUSE THE SYRINGE TO NOT BE RECOGNIZED AND PRODUCE AN ALARM / ALERT INDICATION, OR MAY CAUSE MISIDENTIFICATION OF THE SYRINGE SIZE. IF THE SPRING SLIPPAGE CAUSES THE PUMP TO NOT RECOGNIZE THE SIZE DURING PROGRAMMING OF THE PUMP, THE PROGRAMMING CANNOT BE COMPLETED, AND CAN LEAD TO DELAY IN INITIATION OF AN INFUSION. IF SPRING SLIPPAGE CAUSES THE PUMP TO NO LONGER RECOGNIZE THE SYRINGE SIZE AFTER AN INFUSION HAS BEEN STARTED, AN ALARM WILL BE SOUNDED AND THE INFUSION STOPPED, LEADING TO INTERRUPTION IN THERAPY. IF THE SPRING SLIPPAGE CAUSES MISIDENTIFICATION OF SYRINGE SIZE, THE INFUSION MAY OCCUR AT AN INCORRECT RATE, IF THE CLINICIAN DOES NOT RECOGNIZE THE MISIDENTIFICATION OF SYRINGE SIZE BY THE PUMP AND PROCEEDS WITH INFUSION. THE DEVICE OPERATORS MANUAL WARNS: "IF THE PUMP IS USED TO DELIVER LIFE-SUSTAINING MEDICATIONS, AN ADDITIONAL PUMP MUST BE AVAILABLE FOR SITUATIONS WHERE AN INTERRUPTION IN INFUSION COULD BE DANGEROUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL DEVICE EXPERIENCED OVER-DELIVERY DURING USE ON A PATIENT. IT WAS OBSERVED THAT THE PUMP CHANGED THE SYRINGE SIZE SETTING DURING THE INFUSION. THE PATIENT WAS RECEIVING A NARCOTIC AT THE TIME OF THE EVENT. THE EVENT OCCURRED IN A NEONATAL INTENSIVE CARE UNIT. IT WAS UNKNOWN WHAT THE IMPACT TO THE PATIENT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838518 MEDFUSION® 4000 WIRELESS SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening NARCOTIC