BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM XL3 PLS MIC/MAC

    MDR report key: 1617407 · Received February 25, 2010

    Report

    Report Number
    2921482-2010-00087
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 28, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4)

    Description of Event or Problem · 1

    REPORT 1 OF 2. THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE PT WAS ADMITTED TO THE LABOR AND DELIVERY UNIT IN ACTIVE LABOR. AT 0930, THE DEVICE AS PROGRAMMED TO DELIVER 0.5% MARCAINE 20ML/100ML VIA EPIDURAL AT A RATE OF 14ML/HR AND VTBI (VOLUME TO BE INFUSED) OF 100ML AND THE DELIVERY WAS STARTED. AT APPROXIMATELY 1010, THE NURSE NOTED THAT THE PT WAS HYPOTENSIVE. AT THIS TIME, THE NURSE NOTED LESS SOLUTION THAN EXPECTED IN THE MARCAINE CONTAINER AND THAT THE DEVICE DISPLAYED A RATE OF 124ML/HR. THE CUSTOMER CONTACT INDICATED THAT THE VOLUME INFUSED WAS 105ML. THE NURSE STOPPED THE MARCAINE DELIVERY. THE MOTHER WAS TREATED WITH A BOLUS OF LR (LACTATED RINGERS) AND ADMINISTERED OXYGEN TO THE PT. THE PHYSICIAN WAS NOTIFIED. THE PT WAS TREATED WITH THREE DOSES OF EPHEDRINE 5MG. THE CUSTOMER CONTACT REPORTED THAT "THIS WAS A HUMAN ERROR. THIS WAS RECOGNIZED BY THE ANESTHESIOLOGIST WHO REALIZED HIS ERROR. THE PT DELIVERED BY VAGINAL BIRTH WITH NO SEQUELAE TO PT OR NEWBORN." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3 PLS MIC/MAC 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R MARCAINE, MANUFACTURED BY APP PHARMACEUTICALS