BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3032119 · Received March 6, 2013

    Report

    Report Number
    1314492-2013-00197
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). THE DEVICE WAS REC'D AND EVALUATED BY BAXTER. THE EVAL DID NOT CONFIRM A NOISY OPERATION OR AN INTERMITTENT DELIVERY. A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPECIFICATION. A LOW RATES THE PUMP WILL EXPERIENCE PERIODS OF NO FLOW. AT A RATE OF 0.5ML THE PERIOD OF NO FLOW IS LESS THAN 90 SECONDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SALINE INFUSION AT THE KVO RATE, THE PUMP HAD A NOISY OPERATION AND WOULD INFUSE INTERMITTENTLY. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96554 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER CLEARLINK CONTINUE-FLO (B)(4) IV SET