Oracle Health Transfusion Administration and Bridge Specimen Collection Bridge2016Recalls & reported problems
Cerner Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00853023006104), received between Jul 28, 2025 and Jul 28, 2025 — 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. 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
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Computer Software Problem; Computer Software Problem
ON (B)(6) 2025, A USER SIGNED INTO BRIDGE SPECIMEN COLLECTION SOFTWARE ON MULTIPLE DEVICES WITHIN THE DEPARTMENT. THIS RESULTED IN ACCESSION NUMBERS FOR SPECIMENS LINKING TO THE INCORRECT PATIENT WHICH ULTIMATELY RESULTED IN RESULTS BEING SENT TO THE WRONG PATIENT RECORD. THE ISSUE HAS BEEN RESOLVED FOR THE PATIENT'S RECORDS. CERNER HAS NOT RECEIVED ANY COMMUNICATION REGARDING ANY REPORTS OF ADVERSE PATIENT EVENTS RELATED TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630250 ↗
Other Software, Blood Bank, Stand Alone Products 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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