BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 3171991 · Received June 10, 2013

    Report

    Report Number
    9615050-2013-01571
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT ALARM WHEN A PROXIMAL OCCLUSION WAS PRESENT. THIS IS DUE TO CONTAMINATION ON THE PROXIMAL PRESSURE SENSOR PIN. THE CONTAMINATION PREVENTED THE PROXIMAL PRESSURE SENSOR PIN FROM CORRECTLY CONTACTING THE ADMINISTRATION SET CASSETTE DIAPHRAGM; THEREFORE, THE PUMP DID NOT DETECT PRESSURE CHANGES IN THE PROXIMAL TUBING. THE CONTAMINATION IS A RESULT OF USE IN THE CUSTOMER ENVIRONMENT. THIS REPORT REPRESENTS ALL THE INFO KNOW BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A PROXIMAL OCCLUSION WAS PRESENT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261476 GEMSTAR 7 THERAPY 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA