BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR7 THERAPY PUMP

    MDR report key: 1052465 · Received May 22, 2008

    Report

    Report Number
    2921482-2008-00168
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 28, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K023062
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE SOUNDED A STEADY AUDIBLE TONE THAT DID NOT RENDER THE DEVICE INOPERABLE. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED SOLUTION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED, THE PT HEARD A LONG STEADY BEEPING TONE DURING THERAPY THAT SHOULD HAVE RENDERED THE DEVICE INOPERABLE; HOWEVER, THE DEVICE REPORTEDLY CONTINUED TO DELIVER. THE PT ALERTED THE STAFF. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR7 THERAPY PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK