BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2980526 · Received February 21, 2013

    Report

    Report Number
    9615050-2013-00270
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 24, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON (B)(6) 2013 AT 0024, LINE A WAS PROGRAMMED FOR SIMPLE DELIVERY, PED-CONTINUOUS CCA, TO DELIVER AT TA RATE OF 280ML/HR INSTEAD OF THE INTENDED 20ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 6720ML, FOR A DURATION OF 23HR 11MIN, AND THE DELIVERY WAS STARTED. BETWEEN 0111 AND 0117, THE DEVICE ALARMED FOR N186 (DISTAL OCCLUSION) AND N102 (INFUSION IDLE 2 MINUTES), AND THE DELIVERY WAS RESTARTED. BETWEEN 0146 AND 0149, THE DEVICE ALARMED FOR N186 AND N102, AND THE DELIVERY WAS RESTARTED. AT 0346, PROGRAMMING WAS CANCELLED, AND THE DEVICE WAS REPROGRAMMED TO DELIVER AT A RATE OF 20ML/HR, WITH A VTBI OF 250ML, AND THE DELIVERY WAS RESTARTED. AT 0354, THE DELIVERY STOPPED WITH A VI (VOLUME INFUSED) OF 915.7ML. BETWEEN 0357 AND 0403, THE DEVICE ALARMED TWICE FOR N101 (NO ACTION ALARM) AND THE DEVICE WAS TURNED OFF. A REVIEW OF THE HISTORY INDICATES THE DEVICE DELIVERED AS PROGRAMMED. 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 AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE IV FLUID THAN INTENDED. AT APPROXIMATELY 0000, THE DEVICE WAS PROGRAMMED TO DELIVER 1000ML OF 5% DEXTROSE AND 0.45% NORMAL SALINE WITH 20MEQ OF POTASSIUM CHLORIDE, AT A RATE OF 20ML/HR, AND THE DELIVERY WAS STARTED. AT APPROXIMATELY 0400, IT WAS REPORTED THAT THE DEVICE ALARMED FOR AN UNSPECIFIED OCCLUSION ALARM. IT WAS REPORTED THE ALARM WAS REPORTEDLY RESET AND THE DELIVERY WAS RESTARTED. AT THIS TIME, THE NURSE NOTED THAT THE I.V. FLUID CONTAINER WAS ALMOST EMPTY AND THE DELIVERY WAS STOPPED. THE CUSTOMER CONTACT INDICATED THAT THE NURSE STATED AFTER THE DEVICE WAS TURNED OFF, THE DISPLAY REPORTEDLY "WENT CRAZY" AND FLASHED NUMBER. NO SPECIFIC DETAILS WERE PROVIDED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT. THE PATIENT WAS TREATED WITH UNSPECIFIED CONCENTRATION OF LASIX. IT WAS REPORTED THAT A CHEM 7 BLOOD TEST WAS DRAWN EVERY 2 HOURS TIMES 4. THE RESULTS WERE NOT REPORTED. THE CUSTOMER CONTACT REPORTED THE PATIENT REMAINED STABLE THROUGHOUT. AFTER AN UNSPECIFIED LENGTH OF TIME, THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE CUSTOMER CONTACT INDICATED THAT AFTER A REVIEW OF THE DEVICE HISTORY AT THE USER FACILITY , THE EVENT WAS THE RESULT OF AN OPERATOR ERROR PROGRAMMING THE DEVICE TO DELIVERY AT THE RATE OF 280MML/HR INSTEAD OF THE INTENDED RATE OF 20ML/HR. THE CUSTOMER CONTACT ALSO INDICATED THE NURSE DID NOT USE THE DRUG LIBRARY TO PROGRAM THE DEVICE ACCORDING TO THE USER FACILITY'S POLICY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75221 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Life Threatening| R PLUM A+ SOFTWARE MODULE: LIST#20791, SN# (B)(4)| 20MEQ OF PATASSIUM CHLORIDE: MANUFACTURER - UNK| 5% DEXTROSE: MANUFACTURER - UNK| 0.45% NORMAL SALINE WITH