BEUDAMED
    FDA Adverse Event Death Summary report: N

    3C PCA NEW 802.11 AB

    MDR report key: 3142633 · Received May 24, 2013

    Report

    Report Number
    9615050-2013-01375
    Event Type
    Death
    Date Received
    May 24, 2013
    Date of Event
    February 19, 2010
    Report Date
    February 22, 2010
    Manufacturer
    HOSPIRA, INC
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 DEVICE WAS RETURNED TO CLINICAL USE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A PT DEATH WHILE THE DEVICE WAS IN USE. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED WHILE THE NURSE WAS AT THE PT'S BEDSIDE, THE PT HAD A "SUDDEN CARDIAC EVENT." AT THAT TIME, A CODE WAS CALLED. NO SPECIFIC EVENT DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE PT EXPIRED. THE CUSTOMER CONTACT REPORTED AN AUTOPSY INDICATED THE CAUSE OF THE PT'S DEATH WAS DUE TO A CARDIAC EVENT. THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231008 3C PCA NEW 802.11 AB 80MEA MEA HOSPIRA, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death