BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2934141 · Received December 21, 2012

    Report

    Report Number
    1314492-2012-00529
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BAXTERS HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA 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. THE SPECTRUM INFUSION PUMP KEYPAD LOCK FEATURE IS DESIGNED TO ALLOW FOR THE PUMP TO BE TURNED OFF WHEN STOPPED IN AN ALARM CONDITION AND THE PUMP KEYPAD IS LOCKED. AT THIS TIME, THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS ABLE TO POWER OFF A SPECTRUM PUMP DURING AN INFUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). THE PUMP KEYPAD WAS LOCKED, HOWEVER THE PT TURNED THE PUMP OFF WITHOUT UNLOCKING THE KEYPAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTERS HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1