BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3891537 · Received January 31, 2014

    Report

    Report Number
    1314492-2014-05283
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 6, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE UNIT WAS TESTED FOR 24 HOURS WITH NO OCCURRENCE OF THE REPORTED SYMPTOM. REVIEW OF THE HISTORY LOG CONFIRMED THE REPORTED SYMPTOM. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. THE UPPER AND LOWER AUXILIARY COMPONENTS WERE REPLACED AS THEY ARE KNOWN CONTRIBUTORS TO THE SYSTEM ERROR 322.

    Description of Event or Problem · 1

    A SYSTEM ERROR 322 ALARM WAS FOUND IN THE HISTORY LOG OF A PUMP THAT WAS EVALUATED DURING A SITE VISIT. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68931 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1