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CLIENT SERVER Blood BankRecalls & reported problems

Medical Information Technology, Inc. · MEDITECH's Blood Bank application tightly integrates donor, unit, and patient history information with data in the health care information system (HCIS). The application flags abnormal test results, reports test and transfusion results, minimizes product waste, utilizes expert rules when recording, and performs error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. Authorized users have the ability to view blood bank results from within the network or remotely. All of these features ensure patient safety and reduce turnaround times. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863529000117), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Computer Software Problem1
  • Incorrect Or Inadequate Test Results1
  • Nonstandard Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 11, 2017Computer Software Problem; Nonstandard Device; Incorrect Or Inadequate Test Results

    ON JULY 18, 2017, A MEDITECH CUSTOMER REPORTED THAT IN THEIR LIVE BLOOD BANK SOFTWARE ENVIRONMENT, AN UNVERIFIED TEST RESULT HAD BEEN CHANGED BY THE SYSTEM TO A DIFFERENT RESULT. A USER WAS ENTERING CROSSMATCH RESULTS FOR A RED BLOOD CELL PRODUCT VIA THE BLOOD BANK ENTER/EDIT SPREADSHEET RESULTS ROUTINE. WHEN THE USER VIEWED A COMMENT ASSOCIATED TO ONE OF THE CROSSMATCH COMPONENT TESTS, THE RESULT OF THAT COMPONENT TEST WAS CHANGED. THE CUSTOMER NOTICED THE RESULT CHANGING ON THE SCREEN AS THE PROBLEM WAS OCCURRING AND WAS ABLE TO RESOLVE THE ISSUE THROUGH OTHER MEANS. THE CUSTOMER REPORTED TO MEDITECH THAT THEY WERE ABLE TO REPRODUCE THE ISSUE IN THEIR TEST BLOOD BANK SOFTWARE ENVIRONMENT. MEDITECH INVESTIGATED THE REPORTED MALFUNCTION AND ON JULY 21, 2017, WAS ABLE TO REPRODUCE THE ISSUE IN MEDITECH'S IN-HOUSE, CONTROLLED TESTING ENVIRONMENT. IN ORDER FOR THIS ISSUE TO OCCUR, THE PATIENT MUST HAVE MORE THAN 1 CROSSMATCHABLE RED BLOOD CELL PRODUCTS ON ORDER, AND HAVE THEIR CROSSMATCH COMPONENT TESTS RESULTED VIA A BLOOD BANK SPREADSHEET WHERE THE "COMMENTS" FOOTER BUTTON IS ACCESSED. THIS DECREASES THE LIKELIHOOD OF THIS ISSUE OCCURRING. IF THE RESULT OF A CROSS-MATCHABLE RED BLOO

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6788722 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.