Oracle Health Blood Bank PathNet Blood Bank Transfusion 2018Recalls & reported problems
Cerner Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853023006173), received between Feb 5, 2021 and Feb 5, 2021 — classified as 1 death.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Computer Software Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 5, 2021Computer Software Problem; Computer Software Problem
THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S HNA® MILLENNIUM PATHNET® BLOOD BANK TRANSFUSION (CLASS II, PRODUCT CODE = MMH). THIS ISSUE INVOLVES CERNER'S MILLENNIUM USERS THAT UTILIZE THE COMBINE FUNCTION (HNA COMBINE.EXE) TO COMPLETE AN ENCOUNTER MOVE FOR ONE PATIENT WITH MULTIPLE ABO/RH RESULTS TO A COMBINED PATIENT WITH THE SAME ABO/RH RESULTS. WHEN THIS ISSUE OCCURS, THE ABO/RH IS REMOVED FROM THE COMBINED PATIENT. IF A PATIENT DOES NOT HAVE AN ABO/RH RECORDED IN THE SYSTEM, THE SYSTEM DOES NOT ALLOW USERS TO COMPLETE A CROSSMATCH OR DISPENSE A BLOOD PRODUCT FOR THAT PATIENT. THIS COULD LEAD TO A DELAY IN DISPENSING BLOOD PRODUCTS FOR A PATIENT IF BLOOD BANK PERSONNEL ARE NOT AWARE THAT THE ABO/RH HAS BEEN REMOVED. A NEW ABO/RH RESULT WOULD NEED TO BE ENTERED ON THE COMBINED PATIENT BEFORE THEY CAN DISPENSE BLOOD PRODUCTS VIA THE SYSTEM TO THE PATIENT. CERNER HAS RECEIVED COMMUNICATION ON AN ADVERSE PATIENT EVENT AS A RESULT OF THIS ISSUE. A PATIENT WAS DELAYED A BLOOD PRODUCT TRANSFUSION BECAUSE OF THIS ISSUE. THE PATIENT DID RECEIVE BLOOD PRODUCTS AND WAS PRONOUNCED DECEASED LATER SAME DAY BUT IS UNKNOWN IF THE ISSUE
Patient problems: Insufficient Information
MAUDE report 11288175 ↗
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
- 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
- Instrument Manager 817Data Innovations LLC · Blood Establishment Computer Software And Accessories1 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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