BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM XL PLS MIC/MAC

    MDR report key: 1730100 · Received June 17, 2010

    Report

    Report Number
    2921482-2010-00438
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 18, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K952799
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.0ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/- 1ML (+/- 5%). THE TECHNOLOGY OF THE PLUM XLM LIST #11846 DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMED SETTINGS. 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

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR RESULTING IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE PT WHO WAS IN PRETERM LABOR WAS ORDERED TO RECEIVE A 100ML BOLUS OF MAGNESIUM SULFATE FOLLOWED BY A CONTINUOUS DELIVERY AT A RATE OF 100ML/HR. THE PRIMARY LINE WAS PROGRAMMED TO DELIVER 1000ML MAGNESIUM SULFATE AT A RATE OF 300ML, WITH A VTBI OF 100ML, AND THE DELIVERY WAS STARTED. AFTER 20 MINUTES, THE NURSE REPROGRAMMED THE DEVICE WITH A 900ML VTBI AND RESTARTED THE DELIVERY. THE CUSTOMER CONTACT REPORTED THAT THE NURSE DID NOT REDUCE THE RATE FROM 300ML/HR TO THE INTENDED RATE OF 100ML/HR. AFTER APPROXIMATELY 1 HOUR, THE PT'S FAMILY INFORMED THE NURSE THAT THE PT WAS UNRESPONSIVE. THE DELIVERY WAS STOPPED. THE PHYSICIAN WAS NOTIFIED. THE PT'S MAGNESIUM LEVEL DRAWN WITH RESULTS REPORTED AS 9.3MEQ/L. THE PT WAS TREATED WITH 1GM OF CALCIUM GLUCONATE AND "SLOWLY CAME AROUND." THE PT WAS TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT). THE CUSTOMER CONTACT STATED THAT "WITHIN A COUPLE OF HOURS, THE PT WAS COMPLETELY RECOVERED; HOWEVER WAS COMPLAINING OF NUMBNESS IN HER LEG." THE PT WAS ABLE TO AMBULATE UNASSISTED AND THE CUSTOMER CONTACT REPORTED THAT THE PT'S LEG WAS "ASSESSED AND WORKED THROUGH." LATER THAT MORNING, THE PT WAS TRANSFERRED BACK TO THE LABOR AND DELIVERY DEPARTMENT. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PT'S CONTRACTIONS CEASED AND THE PT WAS DISCHARGED TO HOME. THE CUSTOMER CONTACT INDICATED THAT THE HOSPITAL PROTOCOL IS THAT THE MAGNESIUM SULFATE BOLUS SHOULD HAVE BEEN PIGGYBACK DELIVERY AND THE PRIMARY LINE SHOULD HAVE BEEN THE CONTINUOUS DELIVERY AND THAT THE NURSE DID NOT FOLLOW PROTOCOL WHEN PROGRAMMING THE DEVICE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening| R MANUFACTURER UNK| MAGNESIUM SULFATE