BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM IQ INFUSION PUMP

    MDR report key: 14499473 · Received May 25, 2022

    Report

    Report Number
    1314492-2022-02088
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412610900
    PMA / PMN Number
    K220417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G4 PMA/510K # OR BLA #: K220417. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, 'INFUSION PROBLEM' WAS UNABLE TO BE REPRODUCED. EVALUATION PERFORMED FLOW ACCURACY TESTING WITH PASSING RESULTS WITH ERRORS OF 0.43% AND 0.90% WHICH ARE 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. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION WAS NOT VERIFIED. NO CORRECTION IS REQUIRED. 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 HAD A FLOW ISSUE DURING THE INFUSION OF CITRATE (50 ML/H) RESULTING IN A MARKED DECREASE IN BICARBONATE WHICH LED TO METABOLIC ACIDOSIS AND HAEMODYNAMIC INSTABILITY WITH HIGH FLOW-RATE AMINE REQUIREMENTS. CONTINUOUS VENO-VENOUS HAEMOFILTRATION THERAPY WITH CITRATE AND CALCIUM INFUSIONS WERE STOPPED. THE PATIENT WAS TREATED WITH CALCIUM CHLORIDE SOLUTION AND BICARBONATE SOLUTION (STAT ). PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094957 SPECTRUM IQ INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412610900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CITRATE| SET JC8386