BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY FR

    MDR report key: 2891223 · Received December 21, 2012

    Report

    Report Number
    9615050-2012-01571
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 27, 2012
    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
    FR
    Reporter Occupation
    OTHER

    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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR VARIABLE TIME DELIVERY OF AN UNSPECIFIED CONCENTRATION OF CLAIRIG, AT A RATE OF 31 ML/HR FOR A DURATION OF 1 HR, A RATE OF 54 ML/HR FOR A DURATION OF 1 HR, A RATE OF 80 ML/HR FOR A DURATION OF 4 HRS, A RATE OF 98 ML/HR FOR A DURATION OF 6 HRS AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED AT THE END OF THE DELIVERY THE CONTAINER WAS APPROXIMATELY HALF FULL INSTEAD OF THE EXPECTED EMPTY CONTAINER. AT THAT TIME, THE NURSE REPROGRAMMED THE DEVICE FOR THE REMAINING VOLUME IN THE CONTAINER AND THERAPY WAS COMPLETED USING THE SAME DEVICE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THERE WAS NO CHANGE IN THE STATUS OF THE PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK