BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4022757 · Received March 13, 2014

    Report

    Report Number
    1314492-2014-14452
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 2, 2014
    Report Date
    February 17, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO.: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED SYMPTOM WHICH WAS NOT REPRODUCED. THE DEVICE WAS TESTED AND NO MALFUNCTION COULD BE IDENTIFIED. SYSTEM ERROR 322 WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. THE EVALUATION WAS UNABLE TO DETERMINE THE CAUSE. THE UPPER AND LOWER AUXILIARY ARE KNOWN CONTRIBUTORS TO THIS SYMPTOM AND HAVE BEEN REPLACED. 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. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150666 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1