BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ

    MDR report key: 20855405 · Received December 5, 2024

    Report

    Report Number
    1314492-2024-03756
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    August 21, 2024
    Report Date
    December 5, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K222048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE CUSTOMER REPORTED PROBLEM "NOT INFUSING, AND THAT THE BAG OF OXYTOCIN THAT WAS INFUSING ALL DAY LONG WAS STILL FULL" IN SPECTRUM'S OPERATION MANUAL, THE USER IS INSTRUCTED ON PROPERLY LOADING THE SET PRIOR TO RUNNING AN INFUSION. THE MANUAL WARNS " IMPROPER OR REVERSE IV SET LOADING CAN RESULT IN A NO FLOW CONDITION TO THE PATIENT...". THE CUSTOMER ALSO STATED "THE CLAMP ABOVE THE PUMP WAS STILL CLOSED," WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER IV LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS. THE SPECTRUM'S OPERATION MANUAL WARNS THE USER " ENSURING THAT IV SETS OR CONTAINER VENTS ARE PROPERLY FUNCTIONING, THAT TUBING CLAMPS ARE IN THE PROPER POSITIONS AND THAT TUBING IS FREE FROM KINKS OR SIGNS OF COLLAPSE OUTSIDE THE PUMP TO PREVENT UNDETECTED UPSTREAM OCCLUSIONS.". THE EVENT HISTORY LOG (EHL) REVIEW WAS PERFORMED FOR THE REPORTED PROBLEM. AN INFUSION OF OXYTOCIN PROGRAMMED ON THE REPORTED EVENT DATE AT 09:50 A RATE OF 2 ML/HR AND A VOLUME-TO-BE-INFUSED OF 447ML. AT 10:18 USER UPDATED THE RATE TO 4 ML/HR. AT 11:59 USER UPDATED THE RATE TO 6 ML/HR. AT 12:28 USER STOPPED THE PUMP. 12:30 INACTIVITY ALARM. 12:31 PUMP ENTERED SLEEP MODE. 13:25 PUMP EXITED SLEEP MODE AND THE USER RESUMED THE INFUSION RATE: 2 ML/HR VTBI: 436 ML. 13:47 THE PUMP STOPPED DUE TO AN ¿UPSTREAM OCCLUSION!¿ ALARM. THE USER CLEARED THE ALARM AND RESTARTED THE INFUSION AT THE SAME TIME. BETWEEN 14:03 AND 02:17 08-22 THE USER UPDATED THE FLOW RATE 12 TIMES. AT 03:25 THE FOLLOWING DAY, THE USER STOPPED THE PUMP. IT CANNOT BE DETERMINED IF THE LINE WAS ASSESSED FOR OR CLEARED OF AN UPSTREAM OCCLUSION THROUGH THE HISTORY LOG, HOWEVER PER FA 2021-056, IF AN UPSTREAM OCCLUSION IN THE LINE IS NOT CLEARED AND THE PUMP RESUMED, A SUBSEQUENT ALARM MAY BE DELAYED OR MAY NOT OCCUR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP FAILED TO INFUSE PITOCIN FOR LABOR AND UNDER INFUSED OXYTOCIN WAS DURING THERAPY IN THE INTENSIVE CARE UNIT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085417 SPECTRUM IQ PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 3570009 NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female PITOCIN