BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 2539754 · Received April 13, 2012

    Report

    Report Number
    2245578-2012-00315
    Event Type
    Death
    Date Received
    April 13, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 27, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRELIMINARY INVESTIGATION ON PRODUCT RETURNED AND RETAINS TESTING SHOW NO SIGNS OF A DEFICIENCY OR MALFUNCTION OF THE ACT K CARTRIDGE LOT S11328. THE COMPLETE INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT KAOLIN CARTRIDGES THAT YIELDED DISCREPANT RESULTS. THE PT WAS A REDO TRIPLE BYPASS/AORTIC ARCH DISSECTION. CUSTOMER STATES THE PT WAS IN THE OPERATING ROOM FOR 12 HOURS AND WAS ON BYPASS 3 TIMES DURING WHICH 40 UNITS OF BLOOD, 10 UNITS OF PLATELETS, PLASMA AND CRYOPRECIPITATE WERE GIVEN. 3000 UNITS OF BEBULIN AND 250 MG PROTAMINE WERE GIVEN; 30 K UNITS OF HEPARIN WAS GIVEN TO TREAT THE I-STAT RESULT OF 75. I-STAT 16:11 75 HEMOCHRON: 16:11 >600 50 K UNITS-HEPARIN BEFORE 16:11. I-STAT: 16:17 75 HEMOCHRON 16:30 >600. I-STAT 16:22 75. I-STAT 16:29 75. CUSTOMER STATES THAT THE CASE WAS COMPLICATED AND THE PT DID EVENTUALLY DIE. ABBOTT POINT OF CARE HAS NO REASON TO BELIEVE THAT A PRODUCT PROBLEM EXISTS AT THIS TIME. AN INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA S11328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death