Expanse Blood BankRecalls & reported problems
Medical Information Technology, Inc. · MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863529000148), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Application Program Problem: Parameter Calculation Error1
- Improper or Incorrect Procedure or Method1
- Program or Algorithm Execution Failure1
Patient problems
- Hepatitis1
- Transfusion Reaction1
- Viral Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2025Application Program Problem: Parameter Calculation Error; Improper or Incorrect Procedure or Method; Program or Algorithm Execution Failure; Application Program Problem: Parameter Calculation Error; Improper or Incorrect Procedure or Method; Program or Algorithm Execution Failure
THE ADVERSE EVENT (AE) INVOLVED A USER CONFIGURATION ERROR INVOLVING MEDICAL INFORMATION TECHNOLOGY, INC.'S EXPANSE BLOOD BANK APPLICATION THAT RESULTED IN A PATIENT RECEIVING A CONTAMINATED UNIT OF BLOOD, SPECIFICALLY A UNIT THAT TESTED REACTIVE FOR THE HEPATITIS B VIRUS NAT TEST. THE HOSPITAL ((B)(6)) HAD RECENTLY IMPLEMENTED NEW PROCEDURES FOR DONOR BLOOD SCREENING WHICH INCLUDED NUCLEIC ACID TESTING (NAT). DUE TO THE HOSPITAL'S IMPROPER CONFIGURATION OF THE TEST DICTIONARY AND DEFICIENT BLOOD BANK CALCULATIONS, THE AUTOMATED SAFEGUARDS THAT SHOULD HAVE PROTECTED THE PATIENT FAILED. THIS FAILURE MEANT THE CONTAMINATED BLOOD UNIT WAS NOT PROPERLY MARKED AS "CONTAMINATED" OR REMOVED FROM CIRCULATION, REMAINING AVAILABLE FOR PATIENT ASSIGNMENT, AND WAS SUBSEQUENTLY TRANSFUSED TO A PATIENT, RESULTING IN HARM. ALTHOUGH 32 CONTAMINATED UNITS WERE FOUND AT THE ORGANIZATION, ONLY ONE PATIENT WAS HARMED. THE FAILURE WAS ULTIMATELY ATTRIBUTED TO SETUP AND VALIDATION ERRORS BY THE CUSTOMER.
Patient problems: Hepatitis; Transfusion Reaction; Viral Infection
MAUDE report 23843359 ↗
Other Blood Establishment Computer Software And Accessories devices
- Pyxis TRANSFUSIONCarefusion 303, Inc. · SOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS5 reports
- Regulated Software Application (RSA) 1.0.19.0Oneblood, Inc. · Software, Blood Bank, Stand Alone Products4 reports
- ImmuLINK 0064319Immucor, Inc. · Software, Blood Bank, Stand Alone Products3 reports
- Sunquest Blood Bank 10.0CliniSys, Inc · Blood Establishment Computer Software And Accessories1 report
- Oracle Health Blood Bank PathNet Blood Bank Transfusion 2018Cerner Corporation · Blood Establishment Computer Software And Accessories1 death1 report
- Blood Typing Manager 210404Diagnostic Grifols SA · Blood Establishment Computer Software And Accessories1 report
- Sunquest Blood Bank 11.0.2CliniSys, Inc · Blood Establishment Computer Software And Accessories1 report
- CLIENT SERVER Blood BankMedical Information Technology, Inc. · Software, Blood Bank, Stand Alone Products1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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