BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE BLOOD BANK SYSTEM

    MDR report key: 368730 · Received December 21, 2001

    Report

    Report Number
    2029302-2001-00006
    Event Type
    Other
    Date Received
    December 21, 2001
    Date of Event
    November 13, 2000
    Report Date
    December 20, 2001
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    JQP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2001, A CUSTOMER SITE REPORTED THAT A PT WAS ISSUED A UNIT OF BLOOD OR BLOOD PRODUCT WITH AN ANTIGEN INCOMPATIBILITY IN 2000. THE UNIT OF BLOOD OR BLOOD PRODUCT WAS ORIGINALLY AND CORRECTLY TYPED BY THE USER FACILITY AS POSITIVE FOR THE KELL ANTIGEN. SUBSEQUENTLY, A BLOOD BANK TECHNOLOGIST WHO DID NOT NOTICE THE UNIT HAD BEEN PREVIOUSLY TYPED AS KELL POSITIVE, INCORRECTLY TYPED THE SAME UNIT AS KELL NEGATIVE AND ENTERED THE ERRONEOUS NEGATIVE RESULT INTO THE COMPUTER. BOTH A POSITIVE AND NEGATIVE RESULT FOR THE TYPED UNIT WERE IN THE SYSTEM. THUS, AN INCOMPATIBILITY WARNING WAS NOT GENERATED WHEN THE UNIT WAS SELECTED FOR ISSUANCE TO THE PARTICULAR PT. ALL ANTIGEN TYPINGS ARE DISPLAYED ON THE BLOOD PRODUCT ISSUANCE AND INQUIRY SCREENS AS WELL AS PRINTED ON REPORTS, BUT IN THIS CASE THE USER DID NOT NOTE THE CONTRADICTORY RESULTS. THE POSITIVE KELL UNIT WAS TRANSFUSED TO THE PT WHO REQUIRED A NEGATIVE KELL UNIT. THE PT EXPERIENCED AN UNSPECIFIED REACTION AS A RESULT OF RECEIVING AN INCOMPATIBLE UNIT THAT WAS POSITIVE FOR THE KELL ANTIGEN. SUNQUEST WAS INFORMED OF THIS EVENT WHEN THE CUSTOMER SITE INQUIRED AS TO WHY OPPOSITE ANTIGEN/ANTIBODY TYPES COULD EXIST WITHIN A UNIT'S PERMANENT ANTIGEN/ANTIBODY FIELD. THE DETAILS OF THE REACTION HAVE BEEN REQUESTED BY SUNQUEST BUT HAVE NOT BEEN MADE AVAILABLE BY THE CUSTOMER SITE.

    Description of Event or Problem · 1

    ON 10/2001, A CUSTOMER SITE REPORTED THAT A PT WAS ISSUED A UNIT OF BLOOD OR BLOOD PRODUCT WITH AN ANTIGEN INCOMPATIBILITY ON 11/2000. THE UNIT OF BLOOD OR BLOOD PRODUCT WAS ORIGINALLY AND CORRECTLY TYPED BY THE USER FACILITY AS POSITIVE FOR THE KELL ANTIGEN. SUBSEQUENTLY, A BLOOD BANK TECHNOLOGIST WHO DID NOT NOTICE THE UNIT HAD BEEN PREVIOUSLY TYPED AS KELL POSITIVE, INCORRECTLY TYPED THE SAME UNIT AS KELL NEGATIVE AND ENTERED THE ERRONEOUS NEGATIVE RESULT INTO THE COMPUTER. BOTH A POSITIVE AND NEGATIVE RESULT FOR THE TYPED UNIT WERE IN THE SYSTEM. THUS, AN INCOMPATIBILITY WARNING WAS NOT GENERATED WHEN THE UNIT WAS SELECTED FOR ISSUANCE TO THE PARTICULAR PT. ALL ANTIGEN TYPINGS ARE DISPLAYED ON THE BLOOD PRODUCT ISSUANCE AND INQUIRY SCREENS AS WELL AS PRINTED ON REPORTS, BUT IN THIS CASE THE USER DID NOT NOTE THE CONTRADICTORY RESULTS. THE POSITIVE KELL UNIT WAS TRANSFUSED TO THE PT WHO REQUIRED A NEGATIVE KELL UNIT. THE PT EXPERIENCED AN UNSPECIFIED REACTION AS A RESULT OF RECEIVING AN INCOMPATIBLE UNIT THAT WAS POSITIVE FOR THE KELL ANTIGEN. SUNQUEST WAS INFORMED OF THIS EVENT WHEN THE CUSTOMER SITE INQUIRED AS TO WHY OPPOSITE ANTIGEN/ ANTIBODY TYPES COULD EXIST WITHIN A UNIT'S PERMANENT ANTIGEN/ANTIBODY FIELD. ON 1/2002, ADDITIONAL INFO WAS OBTAINED FROM THE REPORTING SITE PERTAINING TO THE REACTION THE PT EXPERIENCED. THE SITE INDICATED THAT THE REACTION DID NOT RESULT IN DEATH OR SERIOUS INJURY. THE PT DID HAVE A PROLONGED HOSP STAY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58330 FLEXIBLE BLOOD BANK SYSTEM BLOOD BANK, STAND ALONE SOFTWARE PRODUCT JQP SUNQUEST INFORMATION SYSTEMS VERSION 5.3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O