BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 14991216 · Received July 12, 2022

    Report

    Report Number
    1314492-2022-02906
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 16, 2022
    Report Date
    July 12, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, THE REPORTED PROBLEM 'TAKES TOO LONG TO ADMINISTER DRUGS' WAS REPRODUCED. 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 VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A FAILED CAM SHAFT. THE CAM SHAFT REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. DURING EVALUATION THE DEVICE HAD DELAYED KEYPAD RESPONSE. THE CAUSE WAS IDENTIFIED TO BE A FAILED PROCESSOR BOARD. THE PROCESSOR BOARD REPLACEMENT TO CORRECT THE CONDITION. 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 TOOK TOO LONG TO ADMINISTER DRUGS AT 954935; PBLM DES. THE STAFF COMPLAINS THAT IT TOOK TOO LONG TO ADMINISTER DRUGS AT 590/HOUR. THE MEDICATION WAS CHEMO AT ROOM TEMPERATURE. VOLUME TO BE INFUSED WAS APPROXIMATELY 270 ML AT 590 ML, DOSE WAS UNKNOWN. NO INFORMATION ON THE IV SET. THE BAGS COME FROM THE PHARMACY READY TO INFUSE. PRIMARY WAS USED. NO ADD-ONS TO THE IV SET. PATIENT IMPACT WAS THEIR TIME. UNDER INFUSION WAS DETERMINED BY THE LENGTH OF TIME IT TOOK TO DELIVER THE MEDICATION. DISCOVERED THE SAME DAY BECAUSE IT WAS A TIMED DOSE AND TOOK TOO LONG. THE EVENT HAPPENED DURING PATIENT INFUSION AT THE ONCOLOGY DEPARTMENT. 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
    1292766 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown