BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 1.2 MICRON FLTR 244CM

    MDR report key: 3553339 · Received December 5, 2013

    Report

    Report Number
    9615050-2013-05650
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    July 17, 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 ON 10/25/2013. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K060806. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING OF THE TUBING SET AT THE MANUFACTURING FACILITY THAT WAS BEING USED WITH THE GEMSTAR PUMP REPORTED AS 9615050-2013-02421, THE TUBING SET DELIVERED LESS SOLUTION THAN INTENDED. THE INITIAL REPORT INDICATED, "THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION THAT INTENDED. ON AN UNSPECIFIC DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TPM *TOTAL PARENTERAL NUTRITION) IN THE CONTINOUS MODE, WITH A VTBI (VOLUME TO BE INFUSED) OF 4000ML, FOR A DURATION OF 17HRS, WITH A 5ML KVO (KEEP VEIN OPEN) RATE, A 4000ML CONTAINER SIZE AND DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE HOMECARE PATIENT'S HUSBAND REPORTED THE DEVICE HAD AN UNSPECIFIED ALARM OCCURRED THROUGH THE NIGHT. AT THAT TIME, THE PATIENT'S HUSBAND DECIDED TO WAIT UNTIL THE SCHEDULED HOMECARE NURSE VISIT THE NEXT DAY INSTEAD OF CALLING THE HELP LINE. AT AN UNSPECIFIED TIME THE NEXT MORNING, THE HOMECARE NURSE WENT TO THE PATIENT'S HOME. AT THAT TIME, THE NURSE REPORTED APPROXIMATELY 2200ML REMAINED IN THE CONTAINER INSTEAD OF AN EXPECTED UNSPECIFIED VOLUME REMAINING. THE NURSE REPORTED THE DEVICE DISPLAY INDICATED A VOLUME 3322ML HAD BEEN DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL USE. THERE WERE NO REPORTED ADVERSE PATIENT AFFECTS. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE THERAPY WAS RESUMED DURING A REPLACEMENT DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631863 GEMSTAR 1.2 MICRON FLTR 244CM 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT GEMSTAR 7 THERAPY PUMP: LIST #13087, SN UNK