BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    MDR report key: 1022303 · Received April 2, 2008

    Report

    Report Number
    2029302-2008-00003
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    MMH
    PMA / PMN Number
    BK040065
    Removal / Correction Number
    2029302-2008-00003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCENARIO WAS FOUND DURING IN HOUSE TESTING BY QUALITY CONTROL STAFF AT SUNQUEST INFORMATION SYSTEMS. WHILE PERFORMING IN-HOUSE TESTING, IT WAS FOUND THAT THE FOLLOWING QUALITY ASSURANCE WARNINGS/FAILURES ARE NOT GENERATED FOR SOURCE UNITS IN THE ATYPICAL WORKFLOW WHERE A POOLED UNIT IS POOLED WITH ANOTHER UNIT: SELECTED UNIT'S ABO DOES NOT MATCH PT'S PERMANENT ABO(SEE ATTACHED TABLE: TYPE 70 ). SELECTED UNIT'S RH DOES NOT MATCH PT'S PERMANENT RH (SEE ATTACHED TABLE : TYPE 71), SELECTED UNIT'S ABO DOES NOT MATCH SPECIMEN'S ABO. (SEE ATTACHED TABLE:TYPE 72) SLECTED UNIT'S RH DOES NOT MATCH SPECIMEN'S RH (SEE ATTACHED TABLE :TYPE 73) SPECIMEN TESTING ABO DOES MATCH ALLOCATED UNIT'S ABO (SEE ATTACHED TABLE:TYPE 80). SPECIMEN TESTING RH DOES NOT MATCH ALLOCATED UNIT'S RH (SEE ATTACHED TABLE 81). PRIOR TO USING THE SUNQUEST BLOOD BANK APPLICATION, THE TECH HAS POOLED THREE UNITS. WHEN THE TECH DOCUMENTS THE POOLED UNITS USING THE FUNCTION BLOOD COMPONENT PREPARATION (BCP), THE TECH NEGLECTS TO INCLUDE THE THIRD UNIT IN THE POOL. TO CORRECT THE UNIT HISTORY, THE TECH, USING AN ATYPICAL WORKFLOW, POOLS THE THIRD UNIT WITH THE ORIGINAL POOL, CREATING A NEW POOL.

    Description of Event or Problem · 1

    PRELIMINARY INFO ON THE PROBLEM: THE SYSTEM PERFORMS QUALITY ASSURANCE (QA) CHECKING TO DETECT PROBLEMS AND TO DISPLAY WARNINGS AND FAILURES THAT ALERT A TECHNOLOGIST TO PROBLEMS, SUCH AS ABO/RH INCOMPATIBILITIES. WHILE PERFORMING IN-HOUSE TESTING, IT WAS FOUND THAT THE QUALITY ASSURANCE WARNINGS AND FAILURES ASSOCIATED WITH ABO/RH CHECKING ARE NOT GENERATED FOR SOURCE UNITS IN THE ATYPICAL WORKFLOW WHERE A POOLED UNIT IS POOLED WITH ANOTHER UNIT. FOR EXAMPLE, UNITS ARE POOLED TO CREATE UNIT(THIRD) IN THE COMPUTER SYSTEM. IT WAS LATER DISCOVERED THAT UNIT(FOURTH) WAS MISTAKENLY NOT INCLUDED IN THE COMPONENT PREPARATION WITHIN THE COMPUTER SYSTEM WHEN UNIT(THIRD) WAS CREATED. TO CORRECT THE PROBLEM, UNIT(THIRD) IS POOLED WITH UNIT PLT789 TO CREATE UNIT(FIFTH) IN THE COMPUTER SYSTEM. THE QUALITY ASSURANCE WARNINGS/FAILURES ARE EVALUATED CORRECTLY FOR THE SOURCE UNITS, BUT NOT FOR THIS UNITS(FIRST AND SECOND) THAT ARE SOURCE (THIRD)UNITS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNQUEST BLOOD BANK AND BLOOD DONOR MMH SUNQUEST INFORMATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1