BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 1963800 · Received December 22, 2010

    Report

    Report Number
    2921482-2010-01025
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 3, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY OF CRITICAL THERAPY FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF HYDROMORPHONE AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMED 18/00/000 (HISTORY POINTER ERROR) AND 11/004/000 (LITHIUM BATTERY). THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED WITH AN UNSPECIFIED CONCENTRATION OF A "TOPICAL" HYDROMORPHONE. NO MEDICAL INTERVENTIONS WERE REQUIRED. ALTHOUGH THERE WAS POTENTIAL FOR SERIOUS INJURY, THE CUSTOMER CONTACT REPORTED THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR 7 THPY ALT ST 80RN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1