WellSky Transfusion 2022Recalls & reported problems
Wellsky Corporation · WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety. · Class 2
- 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 B105TRANSFUSION0), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- 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.
MalfunctionOct 4, 2024Data Problem; Data Problem
ON SEPTEMBER 6, 2024, WELLSKY WAS NOTIFIED BY A THIRD PARTY OF A CALCULATION ISSUE WITH THE WELLSKY TRANSFUSION SOFTWARE. THIS ISSUE Y OCCURS WHEN THE BLOOD BANK'S SOFTWARE ADMINISTRATOR ("THE ADMINISTRATOR") CONFIGURES THE SYSTEM TO CALCULATE THE COLLECTION DATE FOR MODIFIED OR POOLED PRODUCTS. WHILE THE SOFTWARE FUNCTIONED AS DESIGNED, THE CONFIGURATION SET BY THE ADMINISTRATOR CAUSED THE COLLECTION DATE TO BE CALCULATED INCORRECTLY. THE ADMINISTRATOR HAD CONFIGURED THE SOFTWARE TO CALCULATE THE COLLECTION DATE FOR IRRADIATED RED BLOOD CELLS 28 DAYS PRIOR TO THE KNOWN EXPIRATION DATE. THIS CONFIGURATION CAUSED THE SOFTWARE TO DISPLAY AN INACCURATE COLLECTION DATE TO END USERS, WHICH CAN BE IMPORTANT INFORMATION FOR IMMUNOCOMPROMISED, NEONATAL, OR AT-RISK PATIENTS BASED ON PHYSICIAN ORDER OR BLOOD CENTER STANDARD OPERATING PROCEDURES. THE DISPLAY OF INACCURATE COLLECTION DATES COULD MISLEAD THE END USER ABOUT THE TRUE AGE OF THE PRODUCT. WHILE NO ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THIS INCIDENT, THE TRANSFUSION OF BLOOD PRODUCTS THAT EXCEED THE SPECIFIED AGE REQUIREMENTS FOR AT-RISK PATIENTS COULD POTENTIALLY HAVE NEGATIVE RESULTS. PROPER CONFIGURATION, IN ACCORDANCE WITH IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20375996 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.