BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3050621 · Received March 13, 2013

    Report

    Report Number
    9615050-2013-00370
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 12, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE PUMP DID NOT ALARM WHEN AN UNSPECIFIED OCCLUSION WAS PRESENT. AT AN UNSPECIFIED TIME, ON AN UNSPECIFIED DATE, THE PUMP WAS PROGRAMMED TO DELIVER ORAMORPH AT A RATE OF 61ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2013, AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PUMP DID NOT ALARM WHEN AN UNSPECIFIED OCCLUSION WAS PRESENT. THE DEVICE WAS REMOVED FROM CLINICAL SVC. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED, INCLUDING IF THERE WERE ANY ADVERSE PT EFFECTS OR MEDICAL INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106779 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK