BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLM APL V13.4 ABG

    MDR report key: 1352670 · Received March 26, 2009

    Report

    Report Number
    2921482-2009-00107
    Event Type
    Injury
    Date Received
    March 26, 2009
    Date of Event
    February 27, 2009
    Report Date
    February 27, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED DELAY IN CRITICAL THERAPY. IT WAS REPORTED THE DEVICE HAD BEEN PROGRAMMED TO DELIVER 20ML OF AN UNSPECIFIED BLOOD PRODUCT THROUGH AN "INTRAOSSEOUS SITE IN THE PATIENT'S LEG" DURING A PATIENT ARREST AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE SOUNDED AN ALARM FOR "TOO HIGH OF A PRESSURE." THE DELIVERY WAS STOPPED. THE DELIVERY WAS THEN RESTARTED USING THE PATIENT'S "FEMORAL LINE"; HOWEVER, THE DEVICE AGAIN SOUNDED AN ALARM FOR "TOO HIGH OF A PRESSURE." THE CASSETTE OF THE TUBING SET WAS REMOVED FROM THE DEVICE AND THE CLINICIAN ATTEMPTED TO "SQUEEZE" THE BLOOD PRODUCT BY HAND; HOWEVER, THE BLOOD PRODUCT COULD NOT BE DELIVERED DUE TO "MEETING TOO MUCH PRESSURE." AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT EXPIRED. NO AUTOPSY WAS PERFORMED. THE CUSTOMER CONTACT REPORTED, "WE DO NOT BELIEVE THE PUMP CONTRIBUTED TO THE PATIENT'S DEATH. WE BELIEVE THE CHILD WOULD HAVE DIED BASED ON THE CONDITION COMING IN." THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM APL V13.4 ABG 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Life Threatening| R LOT# UNK| LIFESHIELD HEMA II BLOOD PUMP SET