BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM A+ SPANISH DEVIC

    MDR report key: 2881598 · Received December 17, 2012

    Report

    Report Number
    9615050-2012-01533
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY SHOWS THAT ON (B)(6) 2012 AT 1826, CH A OF THE DEVICE WAS PROGRAMMED TO DELIVER AT A RATE OF 1.0ML/HR, FOR A VTBI OF 45ML, FOR A DURATION OF 45 HOURS, AND THE DELIVERY WAS STARTED. AT 2301, THE DEVICE REPROGRAMMED TO DELIVER AT THE RATE OF 200ML/HR, WITH A VTBI OF 40.4ML, FOR A DURATION OF 12 MINUTES, AND THE DELIVERY WAS STARTED. AT 2313, THE DEVICE ALARMED N161 (VOLUME TO BE INFUSED CH A COMPLETE, THE VTBI WAS REPROGRAMMED FOR 10ML AND THE DELIVERY WAS RESTARTED. BETWEEN 2316 AND 2319, THE DEVICE ALARMED N161, THE ALARM WAS SILENCED TWICE, THE DEVICE ALARMED N250 (DOOR OPEN WHILE PUMPING) AND THE DEVICE WAS RETURNED OFF. A REVIEW OF THE DEVICE HISTORY INDICATES THAT 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 THE PT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER MORPHINE 50MG/50ML, AT A RATE OF 1ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 50ML, AND DELIVERY WAS STARTED. IT WAS REPORTED 40 MINUTES AFTER THE DELIVERY WAS STARTED, THE DEVICE ALARMED THE DELIVERY WAS COMPLETE. AT THAT TIME, THE NURSE NOTED THE PT WAS MORE SEDATED AS A CONSEQUENCE. IT WAS REPORTED THE PT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF NALOXONE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE PT RECOVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. IT WAS REPORTED THE THERAPY WAS NOT RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ SPANISH DEVIC 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MORPHINE: UNK MANUFACTURER| PLUM A+ SOFTWARE MODULE: LIST #12097, SN (B)(4)