BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP

    MDR report key: 2992147 · Received February 27, 2013

    Report

    Report Number
    9615050-2013-00289
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 13, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103224
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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 DELAY OF CRITICAL THERAPY DUE TO A LEAK. THE PLUM BLOOD TUBING SET WAS BEING USED TO DELIVER FRESH FROZEN PLASMA (FFP). THE PT WAS BEING TREATED IN THE MEDICAL INTENSIVE CARE UNIT (ICU) OR A RECURRENT ACTIVE GASTROINTESTINAL (GI) BLEED OF AN UNK ORIGIN. ON UNSPECIFIED DATES, THE CUSTOMER CONTACT REPORTED THAT MULTIPLE UNITS OF PACKED RED BLOOD CELLS (PRC'S), FFP, PLATELETS, AND FACTOR 7 WERE ADMINISTERED TO THE PT VIA A CENTRAL LINE CATHETER. ON (B)(6) 2013 AT 0015, THE PT'S INTERNATIONAL NORMALIZED RATIO (INR) VALUE WAS >8.0. SUBSEQUENTLY, AN UNSPECIFIED AMOUNT OF VITAMIN K WAS ADMINISTERED TO THE PT. AT 0530, IT WAS REPORTED THAT THE PT'S HEMOGLOBIN (HGB) LEVEL WAS 7.3GM/DL WITH A HEMATOCRIT (HCT) OF 22%. AT 1000, IT WAS REPORTED THAT THE PT'S HGB LEVEL WAS 5.5GM/DL WITH A HCT OF 17.0%. AT THIS TIME, IT WAS REPORTED THAT WHEN THE NURSE SPIKED A UNIT OF FFP WITH A "PEEL-AWAY PORT" TYPE CONTAINER, THE SPIKE OF THE TUBING SET PUNCTURED THE CONTAINER OF FFP. IT WAS REPORTED THAT THE CONTAINER OF FFP LEAKED AND WAS NOT DELIVERED TO THE PT. AFTER 45 MINUTES, A REPLACEMENT UNIT OF FFP WAS OBTAINED. AT AN UNSPECIFIED TIME, THE FFP WAS DELIVERED TO THE PT. AT 1055, THE CUSTOMER REPORTED THE PT'S HGB LEVEL WAS 4.5GM/DL. IT WAS REPORTED THAT BETWEEN 1040 AND 1100, THE PT CODED. THE PHYSICIAN WAS NOTIFIED. AT AN UNSPECIFIED TIME, THE PT WAS INTUBATED. AT UNSPECIFIED TIMES, THE PT WAS TREATED WITH UNSPECIFIED AMOUNTS OF EPINEPHRINE AND A NOREPINEPHRINE DRIP. NO SPECIFIED DETAILS WERE PROVIDED. AT AN UNSPECIFIED TIME, THE PT'S FAMILY ARRIVED AND THE PT WAS MADE DO NOT RESUSCITATE (DNR). AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PT WAS DETERMINED TO BE IN PULSELESS ELECTRICAL ACTIVITY (PEA). ON (B)(6) 2013, AT 1235, THE PT EXPIRED. THE MEDICAL DEATH SUMMARY IN THE PT'S MEDICAL RECORD REPORTED THE PT'S CAUSE OF DEATH AS PEA PROBABLY DUE TO HYPOVOLEMIA. NO AUTOPSY WAS PERFORMED. HOSPIRA IS CONTINUING TO INVESTIGATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84458 PLUM Y-BLOOD SET W/FLR CLAVE 110IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death UNSPECIFIED FRESH FROZEN PLASMA (FFP) BAG, MFR UNK