BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4905687 · Received July 6, 2015

    Report

    Report Number
    1314492-2015-07290
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    Z-1484-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVAL WAS ABLE TO CONFIRM THE SYSTEM ERROR 322 WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. THE ALARM COULD NOT BE REPRODUCED AND A CAUSE COULD NOT BE IDENTIFIED. THE PUMP WAS TESTED WITH PASSING RESULTS. BAXTER HAS INITIATED AN APPROVED REMEDIAL ACTION; HOWEVER, THIS DEVICE HAS A VERSION OF SOFTWARE THAT DOES NOT HAVE AN APPROVED SOFTWARE UPDATE. THE DEVICE WAS FOUND TO BE OPERATING MECHANICALLY AS DESIGNED AND NO ACTION WILL BE TAKEN AT THIS TIME. 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. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322 DURING THERAPY (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNK). IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437593 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1