Sunquest Blood Bank 11.0.2Recalls & reported problems
CliniSys, Inc · Blood Bank is intended for use by trained health care professionals responsible for transfusion services. It is intended to: • Record testing results of patient specimens and blood products either manually or through instrument interfaces. • Maintain a historical record of the patient’s blood bank and transfusion related data. • Display data required to assist health care professionals when qualifying patients for electronic crossmatch. • Store records of manufactured and blood product component preparation. • Record the release of manufactured and blood products for infusion. • Maintain manufactured and blood product inventory for lookback. • Print ISBT 128 blood product labels for finished and further processed blood products and products intended for transfer. · 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 B236BB11020), received between Apr 17, 2025 and Apr 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Data 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
- Patient Data 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.
MalfunctionApr 17, 2025Patient Data Problem; Patient Data Problem
CLINISYS RECENTLY IDENTIFIED AN ISSUE INVOLVING BLOOD BANK WITH SUNQUEST INSTRUMENT MANAGER (SIM). THE ISSUE OCCURS WHEN A LABORATORY INSTRUMENT SENDS AN INCOMPLETE MESSAGE FOR A SAMPLE. THIS TRIGGERS A READ TIMEOUT IN OUR SIM OVISION_F DRIVER AFTER 30 SECONDS, RESULTING IN A "TIMED OUT" ERROR MESSAGE FOR THAT INITIAL SAMPLE. HOWEVER, THE DRIVER CAN RETAIN THE PARTIAL DATA TRANSFER IN MEMORY, LEADING TO POTENTIAL DATA MERGING WITH THE SUBSEQUENT SAMPLE'S TRANSMISSION. THERE HAVE BEEN NO INSTANCES OF HARM TO PATIENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861540 ↗
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
- 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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