BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2280368 · Received October 5, 2011

    Report

    Report Number
    2921482-2011-00126
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 7, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING. A 14/001/096 (WATCHDOG ERROR) ALARM CONDITION THAT WAS REPORTED BY THE CUSTOMER CONTACT WAS NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. THE DEVICE HISTORY WAS DOWNLOADED AT THE SVC CTR. A REVIEW OF THE HISTORY INDICATED THE DEVICE WAS PROGRAMMED FOR TPN DELIVERY WITH A 2 HR TAPER UP AND 2 HR TAPER DOWN, A 2550 ML VTBI (VOLUME TO BE INFUSED), A 14 HR DURATION, A 5 ML/HR KVO RATE (KEEP VEIN OPEN), AND A 2580 ML CONTAINER SIZE. ON (B)(6) 2011 AT 2218, THE DEVICE WAS POWERED ON. BETWEEN 2220 AND 2223, A NEW CONTAINER WAS INDICATED, A VOLUME OF 7.6 ML WAS PRIMED, THE DELIVERY WAS STARTED, AND THE TAPER UP BEGAN. A NEW DATE STAMP OF (B)(6) 2011 OCCURRED. AT 0023, THE TAPER UP WAS COMPLETED. AT 0628, A SVC ALARM 9/019/001 OCCURRED. BETWEEN 0632 AND 0651, THE DEVICE WAS POWERED ON, A SVC ALARM 14/001/096 OCCURRED, THE DEVICE WAS POWERED ON, A SVC ALARM 09/006/003 OCCURRED, THE DEVICE WAS POWERED ON AND THEN POWERED OFF. 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 FOR TPN (TOTAL PARENTERAL NUTRITION) DELIVERY, WITH A 2550 ML VTBI (VOLUME TO BE INFUSED), AN UNSPECIFIED TAPER UP AND TAPER DOWN, FOR A DURATION OF 14 HOURS. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT AN UNSPECIFIED TIME THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE HOMECARE PT NOTIFIED THE USER FACILITY THAT THE DEVICE ALARMED 14/001 (WATCH DOG ERROR) AND "19/006" THAT WAS UNABLE TO BE CLEARED. AT THAT TIME, THE PT REPORTED THERE WAS 6 HOURS OF THERAPY REMAINING. THE DEVICE WAS REMOVED FROM CLINICAL SVC. THE CUSTOMER CONTACT INDICATED THAT THE PT WAS OFFERED A REPLACEMENT DEVICE WHICH WOULD BE DELIVERED WITHIN 2 HOURS; HOWEVER, THE PT STATED THAT HE WOULD WAIT UNTIL MORNING. THE CUSTOMER CONTACT INDICATED THAT THE PT WAS INSTRUCTED TO BEGIN DELIVERY OF 10% DEXTROSE, AT AN UNSPECIFIED RATE VIA GRAVITY, AND CHECK THE BLOOD GLUCOSE MORE FREQUENTLY UNTIL THE DEVICE WAS REPLACED. THE FOLLOWING DAY, THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT REPORTED THE PT'S STATUS WAS UNCHANGED. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR