BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PM THERAPY S

    MDR report key: 3022998 · Received March 21, 2013

    Report

    Report Number
    9615050-2013-00461
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING BY DELIVERING A BOLUS DOES WHEN THE BOLUS BUTTON ON THE DEVICE AND WHEN THE BUTTON ON THE BOLUS CORD WAS PRESSED. THE CUSTOMER DID NOT RETURN THE BOLUS CORD; THEREFORE, TESTING QS DONE USING A TEST BOLUS CORD. BASED UPON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT HE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED ON (B)(6) 2013 AT 0644, THE DEVICE WAS PROGRAMMED TO DELIVER IN CONTINUOUS AND BOLUS DELIVERY IN ML, AT A RATE OF 10 ML/HR, 10 ML LOADING DOSE, A 0ML BOLUS DOSE , A 60 MIN. BOLUS LOCKOUT, CONTAINER 235 ML, AND THE DELIVERY WAS STARTED. AT 0842, THE DELIVERY WAS STOPPED AND THE DEVICE WAS POWERED OFF. A REVIEW OF THE DEVIC HISTORY INDICATED THE DEVIC DELIVERED AS PROGRAMMED. 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 ON THE DEVICE WAS PRESSED. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE THAT STATED, "WILL NOT GIVE BOLUS WHEN PCA BUTTON PUSH ON MACHINE." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER A DOSE WHEN THE BOLUS BUTTON ON THE DEVICE OR WHEN THE BUTTON ON THE BOLUS CORD WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117808 GEMSTAR PM THERAPY S 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR BOLUS CORD: LIST # 13027, LOT # UNK