BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR BOLUSCORD (EACH)

    MDR report key: 2903717 · Received January 4, 2013

    Report

    Report Number
    3008785455-2013-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    August 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    HOSPIRA INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    Z-1463-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BOLUS CORD WAS RECEIVED ON (B)(4) AND EVALUATED. TESTING AND INVESTIGATION FOUND THE TEST PUMP INTERMITTENTLY DID NOT DELIVER A BOLUS DOSE WHEN THE BOLUS BUTTON ON THE BOLUS CORD WAS PRESSED. THIS WAS DUE TO A BROKEN WIRE INTERNAL TO THE BOLUS CORD. THE PROBABLE CAUSE OF THE BROKEN INTERNAL WIRE WAS EXCESSIVE STRAIN ON THE BOLUS CORD. THIS DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE INTERMITTENTLY DID NOT DELIVER WHEN THE BOLUS BUTTON WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5179 GEMSTAR BOLUSCORD (EACH) 80FRN FRN HOSPIRA INC. NA UNKG1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA