BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABACUS TPN CALCULATING SOFTWARE

    MDR report key: 870748 · Received June 21, 2007

    Report

    Report Number
    1419106-2007-00002
    Event Type
    Other
    Date Received
    June 21, 2007
    Date of Event
    May 21, 2007
    Report Date
    May 21, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED REQUESTS WERE MADE FOR THE CUSTOMER'S SOFTWARE DATABASE AND BLACK BOX FILES FROM THE SOFTWARE FOR ANALYSIS, HOWEVER, THE CUSTOMER WOULD NOT PROVIDE THE INFORMATION. THE CUSTOMER REPORTED, THAT THERE WERE SEVERAL FACTORS THAT CONTRIBUTED TO THE HIGHER-THAN-DESIRED VOLUME OF NACL. CUSTOMER INDICATED TO BAXA THAT THE PERSON ENTERING IN THE ORDER IN QUESTION TYPED IN 9% INTO ABACUS (TPN) CALCULATION SOFTWARE, WHEN ORDERING THE NACL INSTEAD OF 0.9%. THE VERIFICATION LABEL ALONG WITH THE ASSOCIATED DOCUMENTATION THAT IS PRODUCED WITH THE ORDER OF THE TPN BAG CLEARLY INDICATE THE VOLUME OF NACL IN THE TPN SOLUTION; PHARMACIST AND PHYSICIAN VERIFICATION OF THE TPN BAG FAILED TO IDENTIFY THE HIGHER-THAN-DESIRED VOLUME OF NACL. A REVIEW OF THE PRODUCT HAZARD ANALYSIS (PHA) AND CUSTOMER COMPLAINT DATA FOR THIS PRODUCT WAS CONDUCTED AND IT WAS DETERMINED THAT THIS ISSUE NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN IS EXPECTED FOR THE DEVICE, AS DOCUMENTED IN THE PHA.

    Description of Event or Problem · 1

    ON 5/21/2007, BAXA WAS NOTIFIED OF AN INCIDENT THAT RESULTED IN A PATIENT BEING TRANSFERRED INTO THE ICU. THE CUSTOMER REPORTED, THAT THE PATIENT WAS INFUSED WITH A TPN SOLUTION THAT CONTAINED A HIGHER-THAN-DESIRED VOLUME OF SODIUM CHLORIDE. THE CUSTOMER'S SUBSEQUENT INVESTIGATION REVEALED THAT THE USER ENTERING THE ORDER INTO THE ABACUS TPN CALCULATING SOFTWARE TYPED 9% NACL WHEN THEY INTENDED TO ORDER 0.9% OF NACL. THE CUSTOMER REPORTS THAT THE PATIENT DID NOT EXPERIENCE ANY PERMANENT INJURY/ILLNESS AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABACUS TPN CALCULATING SOFTWARE ABACUS MULTI WORK STATION JQP BAXA CORPORATION 8300-0047 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention