BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 R

    MDR report key: 2820357 · Received October 31, 2012

    Report

    Report Number
    9615050-2012-01279
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING THE DEVICE DELIVERED A MEASURED VOLUME OF 20.2ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML (+/-5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES ON (B)(6) 2012 AT 0921, LINE A WAS PROGRAMMED TO DELIVER AT A RATE OF 100ML/HR, INSTEAD OF THE REPORTED RATE OF 25/ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 45ML, FOR THE DURATION OF 27 MINUTES, AND THE DELIVERY WAS STARTED. BETWEEN 0945 AND 0956, THE DEVICE ALARMED N232 (APPROX AIR A, BACKPRIME), VOLUME INFUSED CLEARED 39ML, ALARMED N101 (NO ACTION ALARM) TWICE, ALARM WAS SILENCED FIVE TIMES, AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE HISTORY INDICATES THAT THE DEVICE DELIVERED AS PROGRAMMED. 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 PT RECEIVED MORE MEDICATION INTENDED. AT 1030, LINE A WAS PROGRAMMED TO DELIVER MAGNESIUM 4MG, AT A RATE OF 25ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 50ML, FOR A DURATION OF TWO HOURS AND THE DELIVERY WAS STARTED. AT 1105, THE NURSE REPORTED THE DEVICE ALARMED FOR AIR IN LINE. AT THAT TIME, THE NURSE NOTED THE MAGNESIUM CONTAINER WAS EMPTY, INSTEAD OF AN EXPECTED 37.5ML. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED THE PT WAS MONITORED FOR 1.5 HOURS AND WAS THEN DISCHARGED TO HOME. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 R 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SN (B)(4)| PLUM A+ SOFTWARE MODULE: LIST# 12097,