Sunquest Blood Bank 10.0Recalls & reported problems
CliniSys, Inc · Sunquest 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 B236BB10000), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of Data” (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
- Loss of Data1
Patient problems
- Unspecified Blood or Lymphatic problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2022Loss of Data; Loss of Data
WHEN NEW GUI BLOOD TYPE COMPATIBILITIES MAINTENANCE DEFINITIONS ARE SAVED TO THE DATABASE, IF THE NUMBER OF OVERALL COMPATIBLE AND SUITABLE DEFINITIONS EXCEEDS 497 LINES OF DATA, ALL DEFINITIONS ARE REMOVED. IF MAINTENANCE IS REMOVED, AND PROBLEM CODE DEFINITIONS WERE DEFINED, PATIENT/UNIT BLOOD TYPE COMPATIBILITIES BASED ON PROBLEM CODE DEFINITIONS WILL NOT BE GENERATED. THIS COULD RESULT IN A PATIENT RECEIVING INCOMPATIBLE BLOOD. MAINTENANCE FOR PATIENT/UNIT BLOOD TYPE COMPATIBILITY (BMA 10,2) ARE NOT AFFECTED BY THIS ISSUE.
Patient problems: Unspecified Blood or Lymphatic problem
MAUDE report 15258905 ↗
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
- 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
- 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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