BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PU,P

    MDR report key: 4344689 · Received April 25, 2014

    Report

    Report Number
    1314492-2014-25649
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATOIN
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD AN UNKNOWN ALARM. ANY PATIENT INVOLVEMENT IS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250361 SPECTRUM INFUSION PU,P INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATOIN 35700

    Patients

    Seq Age Sex Outcome Treatment
    1