BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2801299 · Received October 17, 2012

    Report

    Report Number
    9615050-2012-01239
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 17, 2012
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE LATEST DEVICE HISTORY INDICATED THE DEVICE WAS PROGRAMMED ON (B)(6) 2012 AT 1105, FOR BOLUS ONLY DELIVERY IN MCG, WITH A 10 MCG/ML CONCENTRATION, A 25 MCG BOLUS DOSE, A 5 MINUTE BOLUS LOCKOUT, A 600 MCG 4 HR BOLUS LIMIT, A 100 MCG CONTAINER SIZE, AIR SENSITIVITY AT 2 ML. THE DEVICE CLOCK WAS SET FOR 1100. AT 1101, THE DEVICE WAS POWERED OFF AND ON. BETWEEN 1102 AND 1103, A PRIMING VOLUME OF 57 MCG WAS INDICATED AND THE DELIVERY IS STARTED. AT 1510, A USING EXT BATTERY ALARM OCCURRED. AT 1522, USING AC POWER WAS INDICATED. A NEW DATE OF (B)(6) 2012 OCCURRED. AT 0851, THE DELIVERY WAS STOPPED AND THE DEVICE WAS POWERED OFF. A REVIEW OF THE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. THIS REPORTER 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 AND DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF THE DEVICE DID NOT DELIVER AND DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. NO SPECIFIC PATIENT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES 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
    1 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK