BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5681323 · Received May 26, 2016

    Report

    Report Number
    1314492-2016-03234
    Event Type
    Malfunction
    Date Received
    May 26, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 4, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4) THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND IN SPECIFICATION IN RELATION TO THE REPORTED FLOW RATE ERROR, WHICH WAS NOT REPRODUCED DURING FLOW RATE TESTING. BAXTER'S DEVICE EVALUATION FOUND THE DEVICE TO HAVE PASSING RESULTS WITH THE FOLLOWING TESTS: RATE = 40 ML/ HR, VTBI = 10 ML, DELIVERY = 9.578ML (-4.22%); RATE = 100 ML/HR, VTBI = 25 ML, DELIVERY = 24.046ML (-3.816%); RATE = 400 ML/HR, VTBI = 100 ML, DELIVERY = 94.771ML (-5.229%); RATE = 800 ML/HR, VTBI = 200 ML, DELIVERY = 192.112ML (-3.944%); RATE = 999 ML/HR, VTBI = 250 ML, DELIVERY = 241.133ML (-3.5468%). FLOWRATE DELIVERY WAS FOUND TO BE OUT OF THE ±5% ACCURACY AT VARIOUS RATES ON THE CUSTOMER SUPPLIED IV SET. NO COMPONENT COULD BE IDENTIFIED FOR CAUSALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DELIVERED AT A LOWER RATE OR VOLUME THAN PROGRAMMED (UNDER INFUSION) DURING AN INFUSION OF VANCOMYCIN IN THE MEDICAL SURGICAL UNIT (PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY. ALL THE INFORMATION REGARDING THE PATIENT AND EVENT REPORTED TO BAXTER BY THE CUSTOMER HAS BEEN REFLECTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337370 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1