BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3223883 · Received July 2, 2013

    Report

    Report Number
    1314492-2013-00963
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP WAS EXPERIENCING UPSTREAM OCCLUSION ALARMS WHILE IN USE WITH A MEDIPORT. THE REPORTER STATED THAT THE WORK ORDER FOR THIS PUMP WAS LEFT BY A PREVIOUS TECHNICIAN WHO NO LONGER WORKS THERE. THE REPORTER DID NOT HAVE ANY OTHER DETAILS ABOUT THE ALARMS. SHE DID NOT KNOW IF THEY OCCURRED DURING THERAPY OR TESTING. SHE WAS NOT AWARE OF ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300583 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDIPORT