BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP REFURB

    MDR report key: 2840141 · Received November 13, 2012

    Report

    Report Number
    9615050-2012-01332
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 4, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED AT THE (B)(6) PHARMACY, FOR WEIGHT DOSED DELIVERY OF MILRINONE, WITH A UNIT OF MEASURE OF MG/KG/HR, WITH A PT (B)(6), AT A RATE OF (B)(6), WITH A VTBI (VOLUME TO BE INFUSED) OF 310ML. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE CONTAINER SIZE WAS 350ML. ON AN UNSPECIFIED DATE AND TIME, THE (B)(6) NURSE STARTED THE DELIVERY. ON (B)(6) 2012, AT AN UNSPECIFIED TIME THE PT'S WIFE REPORTED THE DELIVERY COMPLETED AS EXPECTED; HOWEVER, THE DEVICE DID NOT ALARM TO INDICATE THE CONTAINER WAS EMPTY. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR GEMSTAR TUBING SET: LIST #13265, LOT #UNK