MAUDE Adverse Event Report: WELLSKY CORPORATION WELLSKY TRANSFUSION 2022 R3

Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Wellsky transfusion software can calculate the blood collection date when provided the expiration date, based on the administrator-configured properties.Upon initial solution implementation, the administrator establishes the interval between collection and expiration dates for each of the different blood products.This interval varies depending on the type of blood product according to the relevant standards and the specific blood bank's standard operating procedures.The collection date is intended to provide information on the age of the blood product to users within the system.When blood products are pooled or modified by the donor center prior to being received in the software a new expiration date is applied to a blood product.For example, irradiated red blood cells (rbcs) may have an expiration date of 28 days following irradiation or the original expiration date.Because the expiration date for these products can vary, the expiration date for pooled or modified products cannot be formulaically correlated to a collection date, and thus the collection date calculation function should not be used for these types of products.Wellsky transfusion's user documentation provides administrators guidance regarding blood product configuration settings.In response to the reported issue, wellsky updated the documentation to specifically emphasize that collection date calculations should not be used for pooled or modified products.
Event or Problem Description
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 instructions for use, mitigates the risk of issuing or transfusing a blood unit that does not meet the required age criteria.

• Brand Name: WELLSKY TRANSFUSION 2022 R3
• Common Device Name: WELLSKY TRANSFUSION 2022 R3
• Manufacturer (Section D): WELLSKY CORPORATION; 11300 switzer rd; overland park KS 66210
• Manufacturer (Section G): WELLSKY CORPORATION; 11300 switzer rd; overland park KS 66210
• Manufacturer Contact: jon moeckel ; 11300 switzer rd; overland park, KS 66210 ; 9133071000
• MDR Report Key: 20375996
• Report Number: 3006129391-2024-00001
• Device Sequence Number: 18539780
• Product Code: MMH
• UDI-Device Identifier: B105TRANSFUSION0
• UDI-Public: B105TRANSFUSION0
• Combination Product (Y/N): N
• PMA/510(K) Number: BK230826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling,Notification,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown