BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ DRIVER EDITI

    MDR report key: 3017384 · Received March 15, 2013

    Report

    Report Number
    9615050-2013-00390
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. THE REVIEW OF THE HISTORY INDICATES THAT ON (B)(4) 2013 BETWEEN 2310 AND 2311, LINE A WAS PROGRAMMED FOR SIMPLE DELIVERY, AT A RATE OF 999ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 995ML, FOR A DURATION OF 59 MINUTES, THE DEVICE ALARMED N232 (PROXIMAL AIR A, BACKPRIME), BACKPRIME WAS STARTED AND STOPPED 3 TIMES, AND THE DELIVERY WAS STARTED. AT 0010, THE DEVICE ALARMED WITH N161 LINE A VTBI COMPLETE. AT 0021, LINE A WAS PROGRAMMED FOR SIMPLE DELIVERY AT A RATE OF 150ML/HR, WITH A VTBI OF 999ML, THEN THE PROGRAMMING WAS CANCELED. AT 0249, LINE B WAS PROGRAMMED IN THE PIGGYBACK MODE, ANTIBIOTIC, AT A RATE OF 100ML/HR, WITH A VTBI OF 45ML, FOR A DURATION OF 27 MINUTES, AND THE DELIVERY WAS STARTED. AT 0316, THE DEVICE ALARMED WITH N188 (PROXIMAL OCCLUSION B/AIR), LINE B WAS REPROGRAMMED AT A RATE OF 150ML/HR, WITH A VTBI OF 20ML, FOR A DURATION OF 8 MINUTES, AND THE DELIVERY WAS STARTED. AT 0317, LINE A WAS PROGRAMMED FOR A SIMPLE DELIVERY, AT A RATE OF 999ML/HR, WITH A VTBI OF 950ML, FOR A DURATION OF 57 MINUTES, AND THE DELIVERY WAS STARTED. AT 0324, THE DELIVERY ON LINE B WAS COMPLETE. BETWEEN 0332 AND 0340, THE DEVICE ALARMED WITH N186 (DISTAL OCCLUSION), ALARM WAS SILENCED, DEVICE ALARMED N102 (INFUSER IDLE 2 MINUTES) THREE TIMES, AND THE ALARM WAS SILENCED 3 TIMES. AT 0341, LINE A DELIVERY WAS RESTARTED AND LINE B PROGRAMMING CANCELED. AT 0342 LINE A DELIVERY WAS STOPPED. AT 0345, THE DEVICE ALARMED WITH N102 AND THE DEVICE WAS POWERED OFF. 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 PATIENT RECEIVED LESS IV FLUID THAN INTENDED. THE CUSTOMER CONTACT REPORTED THE PATIENT¿S BLOOD PRESSURE WAS IN THE 70¿S AND THAT A FLUID BOLUS WAS NEEDED TO INCREASE THE PATIENT¿S BLOOD PRESSURE. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER NORMAL SALINE AT A RATE OF 999ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 1000ML, AND THE DELIVERY WAS STARTED. APPROX. 1 HOUR LATER, THE DEVICE ALARMED DELIVERY COMPLETE. AT THIS TIME, THE NURSE NOTED THAT ¿THE BAG WAS OVER ½ FULL YET.¿ IT WAS REPORTED THAT DEVICE WAS REPROGRAMMED TO DELIVER USING THE PREVIOUSLY PROGRAMMED PARAMETERS AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT 2 HOURS AFTER THE DELIVERY WAS STARTED, THE SOLUTION CONTAINER ¿STILL HAD FLUID IN IT.¿ THE CUSTOMER CONTACT REPORTED THAT APPROX 3 HOURS AFTER THE DELIVERY WAS STARTED, THE DELIVERY WAS COMPLETE. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THOUGH REQUESTED, NO ADD¿L INFO WAS PROVIDED INCLUDING IF ANY MEDICAL INTERVENTIONS WERE REQUIRED OR THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110466 PLUM A+ DRIVER EDITI 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening SN (B)(4)| PLUM A+ SOFTWARE MODULE: LIST # 20677