BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2143066 · Received June 23, 2011

    Report

    Report Number
    2921482-2011-00083
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. 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 AN OPERATOR ERROR IN PROGRAMMING THE DEVICE WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF GAMUNEX, AT A VARIABLE RATE OF 45ML/HR FOR A DURATION OF 30MINS, 65ML/HR FOR DURATION OF 30MINS, 85ML/HR FOR DURATION OF 30MINS, 95ML/HR FOR A DURATION OF 30MINS, AND 100ML/HR FOR A DURATION OF 90MINS AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE PHYSICIAN ORDERED A TOTAL DOSE OF 30GM TO BE DELIVERED IN SEPARATE DELIVERIES OF 20GM AND 10GM. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THE NURSE REPROGRAMMED THE DEVICE TO DELIVER AT AN UNSPECIFIED RATE AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE NOTED THE MEDICATION CONTAINER WAS EMPTY. IT WAS REPORTED THAT AIR WAS NOTED IN THE TUBING SET DISTAL TO THE DEVICE, DOWN TO THE PATIENT, WITH NO PUMP ALARM. AT THIS TIME, THE NURSE REPORTED THE PATIENT WAS DYSPNEIC, PALE, AND DIAPHORETIC. THE CUSTOMER CONTACT COULD NOT SPECIFY IF AIR WAS DELIVERED TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM FOR OBSERVATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT RETURNED TO THE OUTPATIENT DEPARTMENT TO COMPLETE THE REMAINING 10GRAMS OF GAMUNEX THERAPY USING THE SAME DEVICE. THE PATIENT WAS DISCHARGED HOME AFTER COMPLETING THE THERAPY. DURING A REVIEW OF THE DEVICE HISTORY BY THE USER FACILITY, THE CUSTOMER CONTACT INDICATED THE DEVICE WAS PROGRAMMED WITH THE AIR IN LINE SENSITIVITY OFF AND THE DEVICE WAS PROGRAMMED TO DELIVER AT A RATE THAT WAS "TWO TIMES TO QUICKLY"; HOWEVER, NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF MEDICAL INTERVENTION 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 47 YR Required Intervention GAMUNEX, MANUFACTURER UNK