BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 1942129 · Received November 12, 2010

    Report

    Report Number
    2921482-2010-00887
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING AND PRODUCED AUDIBLE AND VISUAL ALARMS FOR LOW BATTERY WHEN THE BATTERY CHARGE WAS ALMOST DEPLETED. BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE MFG FACILITY. NO POWER LOSS ALARMS NOTED IN THE HISTORY WHILE THE DEVICE WAS OPERATING ON BATTERY OR AC POWER. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL; (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT WHILE OPERATING ON BATTERY POWER, THE PUMP POWERED OFF BY ITSELF W/O SOUNDING AN AUDIBLE ALARM TONE. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED FOR CONTINUOUS DELIVERY OF PENICILLIN 21 MILLION UNITS AT A RATE OF 20ML/HR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER REPORTED THE DURATION OF THE DELIVERY WAS FOR 24 HRS. AFTER AN UNSPECIFIED LENGTH OF TIME, THE HOMECARE PT WENT TO THE USER FACILITY FOR A NEW CONTAINER OF MEDICATION. AT THAT TIME, THE NURSE NOTED THE PUMP WAS POWERED OFF AND THE CONTAINER WAS FULL. THE PT REPORTED THE PUMP WAS OPERATING ON BATTERY POWER AND THAT THERE WAS NO PUMP ALARM DURING THE DELIVERY. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THE PHYSICIAN WAS NOTIFIED. THE CUSTOMER CONTACT REPORTED THE PT DID MISS A DOSE OF MEDICATION; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE PROVIDED. 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 58 YR GEMSTAR TUBING SET, LIST #13273, LOT #880085H