BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 12801332 · Received November 11, 2021

    Report

    Report Number
    1314492-2021-04419
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Report Date
    December 14, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS TESTED FOR FLOW RATE ACCURACY PER THE SERVICE MANUAL AND THE RESULTING VALUE WAS AN OVER DELIVERY OF 12%. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. BAXTER RECEIVED AND EVALUATED THE DEVICE.  VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION.  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. THE DEVICE WAS TESTED FOR FLOW ACCURACY AND DELIVERED WITHIN SPECIFICATION.  NO CORRECTION IS REQUIRED.  SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 HAD AN ERROR OF 12% +. IT WAS CLARIFIED THAT THE PERCENTAGE VALUE LISTED WAS BASED ON THE RESULTS OF THE FLOW ACCURACY TEST. IT WAS CONFIRMED THAT THE MINUS SIGN MEAN THAT PUMP DELIVERED AT A LOWER RATE WHILE POSITIVE SIGN MEAN PUMP DELIVERED AT A HIGHER RATE. IT WAS STATED, 'DELIVERY RATE WAS SET TO 200ML/HOUR, VOLUME TO BE INFUSE (VTBI) WAS SET TO 50ML (COLLECTION VESSEL WAS A 60ML GRADUATED CYLINDER). THE PUMP % ERROR WAS CALCULATED BY DIVIDING THE MEASURED VOLUME DELIVERED BY THE PROGRAMMED VOLUME, SUCH THAT PUMP SERIAL NUMBER 2122329 DELIVERED 59 ML WHEN PROGRAMMED TO DELIVER 50 ML'. THE EVENT HAPPENED DURING TESTING AT THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698822 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown