BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR BULUSCORD (EACH)

    MDR report key: 3915183 · Received May 16, 2014

    Report

    Report Number
    3008785455-2014-00006
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 18, 2014
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT DELIVER A DOSE WHEN THE BOLUS BUTTON WAS PRESSED. THE BOLUS CORD WAS RETURNED TO THE PHARMACY DEPARTMENT FROM THE HOMECARE SETTING WITH A REPORT OF THE BOLUS CORD DID NOT DELIVER WHEN THE BOLUS BUTTON WAS PRESSED. IT WAS REPORTED THAT THE BOLUS CORD WAS CONNECTED TO A GEMSTAR PUMP AND WAS BEING USED TO DELIVER AN UNSPECIFIED PAIN MEDICATION. NO SPECIFIC PUMP PROGRAMMING WAS AVAILABLE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE REPORTED TO THE PHARMACY THAT WHEN THE BOLUS BUTTON ON THE BOLUS CORD WAS PRESSED, THE DEVICE DID NOT DELIVER A DOSE. IT WAS REPORTED THAT THE THERAPY WAS RESUMED BY PRESSING THE MANUAL BOLUS BUTTON ON THE PUMP. AT AN UNSPECIFIED TIME, THE BOLUS CORD WAS REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293272 GEMSTAR BULUSCORD (EACH) 80FRN FRN HOSPIRA, INC. NA UNKG1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED GEMSTAR PUMP, LIST #UNK, SN UNK