BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 1590997 · Received January 28, 2010

    Report

    Report Number
    2921482-2010-00033
    Event Type
    Other
    Date Received
    January 28, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 30, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE MANUFACTURING FACILITY. THE PUMP HISTORY INDICATES THAT ON (B) (6) 2009 AT 1010, LINE A OF CHANNEL 1 WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER FENTANYL 25MCG/1ML WITH A DOSE OF 50MCG/HR FOR A DURATION OF 16 HOURS, 45 MINUTES, AND A RATE OF 2ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 33.5ML AND THE DELIVERY WAS STARTED. AT 1011, LINE B OF CHANNEL 1 WAS PROGRAMMED IN THE PIGGYBACK MODE TO DELIVER AT A RATE OF 999ML/HR AND VTBI OF 1ML AND THE DELIVERY WAS STARTED. WITHIN THE SAME MINUTE, THE SETTINGS ON LINE A WERE CLEARED AND LINE A WAS REPROGRAMMED TO DELIVER AT A RATE OF 150ML/HR AND VTBI OF 650ML FOR A DURATION OF 4 HOURS, 20 MINUTES AND THE DELIVERY WAS STARTED. AT 1022, THE DELIVERY ON LINE A WAS STOPPED WITH A VOLUME INFUSED OF 27.3ML. A REVIEW OF THE PUMP HISTORY INDICATES THAT THE PUMP DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR TREATMENT OF PNEUMONIA WITH SEVERE SEPSIS AND SHOCK. AT AN UNSPECIFIED TIME, CHANNEL 1 OF THE DEVICE WAS PROGRAMMED TO DELIVER FENTANYL 25MCG/ML WITH A DOSE OF 50MCG/HR AT A RATE OF 2ML/HR, AND THE DELIVERY WAS STARTED. AT APPROXIMATELY 0900, THE PATIENT "RESPIRATORY ARRESTED AFTER THE RN DID A 50MCG BOLUS OF FENTANYL." THE DELIVERY WAS STOPPED. AT THIS TIME, THE NURSE NOTED, THE DEVICE DISPLAYED A RATE OF 150ML/HR. THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS "BAGGED" AND WAS TREATED WITH NARCAN 0.4MG. THE PATIENT "RESPONDED IMMEDIATELY." NO INTUBATION WAS REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AT 1700, THE THERAPY WAS RESUMED USING A TOPICAL PATCH. NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT REPORTED, "WE FEEL IT WAS AN OPERATOR/NURSE ERROR AND NOT A PUMP ERROR." THE PATIENT WAS DISCHARGED ON (B) (6) 2010. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ TRIPLE NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R FENTANYL