BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLMA DVC C11.51 1 N

    MDR report key: 2902969 · Received December 26, 2012

    Report

    Report Number
    9615050-2012-01595
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 6, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED. THIS REPORT REPRESENT ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER REMICADE 300G/250ML, AT A RATE OF 200ML/HR, FOR A DURATION OF 1 HOUR AND 17 MINUTES, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT INDICATED THAT THE SCHEDULED REMICADE THERAPY WAS ORDERED BY THE PHYSICIAN WITH A ONE HOUR DURATION; HOWEVER, THE PATIENT PREFERS THAT THE MEDICATION IS DELIVERED WITH A LONGER DURATION. AFTER 44 MINUTES, THE CUSTOMER CONTACT REPORTED THE PATIENT COMPLAINED OF UPPER LIP FULLNESS. AT THAT TIME, IT WAS REPORTED THAT THE PATIENT'S LIP EDEMA WAS OBSERVED BY THE NURSE, AND THAT THE NURSE NOTED THE "REMICADE INFUSION WAS ALMOST ENTIRELY INFUSED DESPITE THE PUMP BEING SET STILL AT THE SAME RATE." THE CUSTOMER CONTACT REPORTED THE DELIVERY WAS STOPPED, THE DEVICE WAS REPROGRAMMED TO DELIVER AT A RATE OF 150ML/HR, AND THE REMICADE DELIVERY WAS RESTARTED. IT WAS REPORTED THAT THE REMICADE THERAPY COMPLETED 1 HOUR FROM THE START OF THE DELIVERY. THE CUSTOMER CONTACT REPORTED THE PATIENT WAS GIVEN AN UNSPECIFIED AMOUNT OF REACTINE PROPHYLACTICALLY, AND THE PATIENT WAS ASSESSED BY THE PHYSICIAN.. THE CUSTOMER CONTACT REPORTED WITHIN MINUTES OF TURNING THE DELIVERY OFF AND DECREASING THE RATE, THE PATIENT'S LIP EDEMA DECREASED. AFTER THE DELIVERY WAS COMPLETED, THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC C11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

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