BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2860204 · Received November 21, 2012

    Report

    Report Number
    9615050-2012-01404
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED FOR AIR IN LINE WHEN NO AIR WAS PRESENT IN THE TUBING SET. THIS WAS DUE TO A BROKEN AIR SENSOR. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATES THE DEVICE WAS NOT POWERED DURING THE REPORTED EVENT DATE OF (B)(6) 2012; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION FOR EPIDURAL DELIVERY AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER LESS THAN 5 MINUTES, THE NURSE REPORTED THE PUMP ALARMED FOR AIR IN LINE; HOWEVER, NO AIR WAS NOTED IN THE TUBING SET. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AFTER APPROX 5-10 MINUTES THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS. NO MEDICAL INTERVENTION WAS REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR TUBING SET: LIST #UNK, LOT #UNK