BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHNET BLOOD BANK DONOR

    MDR report key: 88156 · Received April 24, 1997

    Report

    Report Number
    1931259-1997-00001
    Event Type
    Malfunction
    Date Received
    April 24, 1997
    Date of Event
    November 15, 1996
    Manufacturer
    CERNER CORP.
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE ORIGINAL REPORT, A SOFTWARE MODIFICATION WAS INSTITUTED TO CORRECT THIS ISSUE. THE MODIFICATION WAS DOCUMENTED WITH PIM 30558. THIS PIM WAS INCLUDED ON REVISION LEVEL 51, WHICH WAS AVAILABLE TO CERNER CLIENTS ON 8/14/96. THIS ISSUE WAS INCLUDED AS PART OF CERNER RECALL 97-001. THIS RECALL HAS BEEN CLASSIFIED AS A CLASS II RECALL BY THE FDA AND ASSIGNED THE NUMBER B-1463-7. CERNER HAS CONFIRMED THAT ALL POTENTIALLY-AFFECTED CLIENTS HAVE BEEN NOTIFIED OF THIS ISSUE. IN ADDITION, CERNER IS MONITORING THE INSTALLATION OF THE SOFTWARE MODIFICATION AT EACH SITE AND WILL CONTINUE TO DO SO UNTIL ALL SITES HAVE MIGRATED THE MODIFICATION INTO THEIR PRODUCTION ENVIRONMENT. CERNER CORPORATION IS WORKING CLOSELY WITH THE KANSAS CITY DISTRICT OFFICE TO ENSURE THE RECALL PROCEEDS IN A MANNER ACCEPTABLE TO FDA.

    Description of Event or Problem · 1

    ON DECEMBER 4, 1996, RECEIVED A COPY OF UIHCS ERROR/ACCIDENT REPORT FROM ALICE FLOSS, SECTION MANAGER AT DEGOWIN BLOOD CENTER. THE REPORT WAS DATED NOVEMBER 25, 1996 AND WAS SIGNED BY DR. RONALD STRAUSS, MEDICAL DIRECTOR, OF DEGOWIN BLOOD CENTER. THE REPORT INDICATED THAT AN ERROR WAS DETECTED WHEN AN APHERESIS DONOR COLLECTED ON 11/15/96 WAS NOTED TO HAVE A DISCREPANT ABO/RH BLOOD TYPE. THE REPORT INDICATED THAT FURTHER INVESTIGATION AND A REVIEW OF THE DONOR DATABASE LOCATED 13 DONORS WITH DISCREPANT TYPES FROM PREVIOUS COLLECTIONS AND FURTHER NOTED THAT ONE OF THE DONOR UNITS HAS BEEN INCORRECTLY LABELED. IN REVIEWING COS SERVICE CENTER RECORDS FOR THIS CLIENT, CO DETERMINED THAT FACILITY FIRST REPORTED THIS ISSUE ON NOVEMBER 18, 1996 AT 09:33 CDT. THE REQUEST WAS ASSIGNED THE ACCESSION NUMBER 96-323-00199 TO LOG THE CALL AND DOCUMENT ITS RESOLUTION. COS INVESTIGATION INTO THIS REQUEST IDENTIFIED A SOFTWARE ISSUE WITH THE BATCH RESULTING OF DONOR ABO/RH TESTING IN THE FUNCTION SRE, SCROLLING RESULT ENTRY, WHEN ONE OR MORE OF THE UNITS IN THE BATCH ARE IN A "QUARANTINED" 03) STATUS. SRE DOES NOT RECOGNIZE QUARANTINED (03) AS A DONOR STATUS. CONSEQUENTLY, WHEN AN ABO/RH PROCEDURE IS RESULTED ON A DONATED UNIT IN A "QUARANTINED" (03) STATUS, THE BLOOD GROUP/TYPE OF THAT DONOR, OR ANY DONOR ON SUBSEQUENT UNITS IN THE SAME BATCH, WILL NOT BE APPROPRIATELY UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHNET BLOOD BANK DONOR BLOOD BANK SOFTWARE MMH CERNER CORP. HNA RELEASE 306 REV 43

    Patients

    Seq Age Sex Outcome Treatment
    1 *