BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6576800 · Received May 18, 2017

    Report

    Report Number
    1314492-2017-00936
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Date of Event
    April 1, 2017
    Report Date
    June 15, 2017
    Manufacturer
    BAXTER HEALTHCARE - MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW CONFIRMED THE LAST INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB) WAS INSTALLED IN THE DEVICE WAS REVISION G, WHICH REQUIRES REPLACEMENT. A SERVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE AND DID NOT REVEAL ANY EVIDENCE OF NONCONFORMING PRODUCT. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED 'SYSTEM ERROR 322' ALARMS WHICH WERE NOT REPRODUCED. 'SYSTEM ERROR 322' ALARMS WERE VERIFIED THROUGH A REVIEW OF THE EVENT HISTORY LOG AND FOUND TO BE CAUSED BY AN I/O PCB THAT REQUIRED REPLACEMENT. THE I/O PCB WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP EXPERIENCED A SYSTEM ERROR 322 (LINK SWITCH ERROR (LOW)) ALARM. THERE WAS NO KNOWN 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
    358615 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE - MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1