BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6422044 · Received March 21, 2017

    Report

    Report Number
    1314492-2017-00499
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Report Date
    March 21, 2017
    Manufacturer
    BAXTER MEDINA
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE REPORTED CONDITION ¿SYSTEM ERROR 324¿ WAS NOT VERIFIED OR REPRODUCED DURING DEVICE EVALUATION. COMPONENT CAUSALITY COULD NOT BE DETERMINED FOR THE REPORTED SYMPTOM. THE EVENT HISTORY LOG ALSO SHOWED EVIDENCE OF SYSTEM ERROR 224 ALARMS, WHICH WERE REPRODUCED DURING EVALUATION. DEVICE EVALUATION DETERMINED THAT THE CUSTOMER MAY HAVE INTENDED TO REPORT SYSTEM ERROR 224 AND REPORTED SYSTEM ERROR 324 BY ERROR. SYSTEM ERROR 224 WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED 'SYSTEM ERROR 224' ALARMS WHICH WERE REPRODUCED AND FOUND TO BE CAUSED BY AN FAILED PROCESSOR PRINTER CIRCUIT BOARD. THE PROCESSOR PRINTER CIRCUIT BOARD WAS REPLACED TO CORRECT THIS CONDITION. A NONCONFORMANCE WAS NOT INITIATED BECAUSE REVIEW OF THE EVALUATION ELEMENTS DID NOT IDENTIFY NONCONFORMING PRODUCT. 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 324 (COLOR SENSOR ERROR: FRQ) 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
    204074 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER MEDINA N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1