BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMPTY CONTAINER

    MDR report key: 1613681 · Received February 5, 2010

    Report

    Report Number
    9615050-2010-00018
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    November 19, 2009
    Report Date
    January 6, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    KPE
    PMA / PMN Number
    K771228
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THAT THE EVENT COULD HAVE BEEN THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE IV PUMP. PRODUCT LABELING STATES: "100ML EMPTY CONTAINER, SINGLE USE I.V. CONTAINER FOR ADMIXING COMPATIBLE MEDICATIONS." (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR, RESULTING IN THE PATIENT RECEIVING MEDICATION FASTER THAN INTENDED. THE EMPTY FLEXIBLE 100ML CONTAINER HAD BEEN FILLED IN THE PHARMACY WITH 55ML OF ALTEPLASE. IT WAS REPORTED THAT THE PHARMACIST LABELED THE CONTAINER WITH THE ALTEPLASE DRUG ADDITIVE PRESCRIPTION INFORMATION ON THE BACK OF THE CONTAINER. SUBSEQUENTLY, THE NURSING STAFF RECEIVED THE FILLED CONTAINER AND READ THE "100ML EMPTY CONTAINER" ON THE FRONT OF THE CONTAINER AND DID NOT READ THE PHARMACY LABEL ON THE BACK OF THE CONTAINER THAT INDICATED THAT THE CONTAINER HAD A 55ML FILL VOLUME. THE NURSE PROGRAMMED THE INFUSION PUMP TO DELIVER 100ML FOR A DURATION OF ONE HOUR INSTEAD OF THE INTENDED 55ML OF THE ALTEPLASE FOR A DURATION OF ONE HOUR. IT WAS REPORTED THAT WHEN THE NURSE PROGRAMMED THE PUMP FOR DELIVERY, THE PUMP DISPLAYED AN ERROR MESSAGE THAT THE PROGRAM WAS "NOT CORRECT"; HOWEVER, THE NURSE CHOOSE TO CONTINUE WITH THE DELIVERY. REPORTEDLY THE PUMP DELIVERED THE 55ML VOLUME OF MEDICATION IN 15 MINUTES AND THE PATIENT SUBSEQUENTLY BECAME MENTALLY UNRESPONSIVE. THE NURSES THEN NOTED THE MEDICATION WAS ADMINISTERED TOO QUICKLY. THE PATIENT WAS TRANSFERRED TO RADIOLOGY FOR A CT SCAN OF THE HEAD TO RULE OUT A "BLEED." THE PATIENT WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ON (B) (6) 2009, THE PATIENT WAS REPORTED TO BE AWAKE BUT STILL INTUBATED. ON (B) (6) 2009, THE PATIENT WAS EXTUBATED. THE PATIENT WAS TRANSFERRED OUT OF ICU ON AN UNSPECIFIED AND WAS DISCHARGED FROM THE HOSPITAL ON (B) (6) 2009. AT DISCHARGE, ACCORDING TO FAMILY MEMBERS, THE PATIENT'S STATUS WAS REPORTED AS "MAYBE AT BASELINE." THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPTY CONTAINER 80KPE KPE HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R ALTAPLASE, MFG BY GENENTECH, INC.| UNSPECIFIED ALARIS PUMP MFG BY CAREFUSION CORP