BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 13938948 · Received March 29, 2022

    Report

    Report Number
    1314492-2022-01158
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 2, 2022
    Report Date
    April 14, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. DURING FUNCTIONAL TESTING, AN UPSTREAM OCCLUSION ALARM WAS NOT REPRODUCED AND THE ULTRASONIC SENSOR WAS WITHIN THE CALIBRATED SPECIFICATION. TROUBLESHOOTING THE DEVICE REVEALED NO HARDWARE OR SOFTWARE ABNORMALITIES THAT WOULD INDUCE THE REPORTED ALLEGATION. A REVIEW OF THE EVENT HISTORY LOG REVEALED UPSTREAM OCCLUSION MESSAGES. THE ALARMS IN THE LOG WERE LIKELY A RESULT OF NORMAL PUMP OPERATION. HOWEVER, THE LOG ONLY CANNOT BE USED TO CONFIRM THE REPORTED PROBLEM. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.. THE REPORTED CONDITION WAS VERIFIED. NO CORRECTION IS REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    RECEIVED VIA MEDWATCH REPORT NUMBER (B)(4). A1: PATIENT IDENTIFIER ORIGINALLY NONE BUT SHOULD BE UNKNOWN., A1, A2, A3 AND A4 WERE ORIGINALLY NA AND SHOULD BE NI. B5: IT WAS REPORTED THAT A SPECTRUM PUMP HAD A MEDICATION INFUSED VIA PRIMARY INFUSION. INFUSION PARAMETERS ARE AS FOLLOWS: PRIMARY INFUSION PARAMETERS: MEDICATION - NOREPINEPHRINE, PRIMARY IV SET - 2C8537, VOLUME TO BE INFUSED (VTBI) 22.8ML, DOSE: 0.03 MCG/KG, FLOW RATE 9.36ML/HR. THE HEAD HEIGHT OF THE PRIMARY BAG WAS 16 (INCHES). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. B5, AND B6: NONE TO UNKNOWN. D10: CONCOMITANT PRODUCT: NOREPINEPHRINE; 03-02-2022. E4: REPORTER SENT TO FDA? YES. F10/H6: HEALTH EFFECT - IMPACT CODES NEEDS TO GO FROM F27 TO F26. F10/H6: MEDICAL DEVICE PROBLEM CODES: A140304 . 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 ALARMED UPSTREAM OCCLUSION DURING TESTING AT THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793958 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOREPINEPHRINE