BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14711751 · Received June 16, 2022

    Report

    Report Number
    1314492-2022-02511
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 6, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K220417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED MEDWATCH 0700220000-2022-8128 FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 EVENT DESCRIPTION: THE REPORTER CONFIRMED THAT "PTT" REFERRED TO PARTIAL THROMBOPLASTIN TIME. THE PROGRAMMED FLOW RATE FOR HEPARIN WAS INITIALLY 6.7ML/HR. WHEN A NEW ORDER WAS PROGRAMMED 12 HOURS LATER, THE RATE WAS INCREASED TO 11.2ML/HR. IT WAS INCREASED 9 HOURS LATER TO 15.6ML/HR AND RAN FOR 5 HOURS BEFORE STOPPING. THE FOLLOWING INFORMATION WAS UNKNOWN: HEAD HEIGHT OF THE INFUSION BAG AND THE PUMP, RIGID VS. FLEXIBLE CONTAINER, WAS CONTAINER VENTED, WAS BLUE SLIDE CLAMP REMOVED FROM PUMP KEYHOLE, WAS BLUE SLIDE CLAMP COMPLETELY DISENGAGED FROM THE INTRAVENOUS TUBING, WAS THERE AN UPSTREAM ROLLER CLAMP (IF YES, WAS IT RELEASED). PMA/510K # OR BLA #: K220417. H10: THE EVENT HISTORY LOG REVIEW REVEALED NO MESSAGES RELATED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE REPORTED ISSUE COULD NOT BE REPRODUCED. FLOW RATE ACCURACY TESTING WAS PERFORMED, AND THE RESULTS WERE WITHIN SPECIFICATION. A SERVICE HISTORY REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE HAS NO PREVIOUS SERVICE EVENTS; THEREFORE, SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE REPORTED CONDITION WAS NOT VERIFIED. THERE IS CURRENTLY AN OPEN FIELD ACTION (FA-2021-056) ASSOCIATED WITH REINFORCING PROPER INTRAVENOUS LINE SETUP AND DETECTION OF UPSTREAM OCCLUSION FOR SPECTRUM PUMPS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SPECTRUM IQ PUMP UNDER INFUSED DURING HEPARIN THERAPY AT A PATIENT'S ROOM. THE PUMP ALARMED INFUSION COMPLETE HOWEVER, THE HEPARIN BAG WAS STILL FULL AND ALL CLAMPS WERE STATED TO BE OPEN. 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
    1254551 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HEPARIN