MAUDE Adverse Event Report: HAEMONETICS CORPORATION SAFE TRACE TX; SAFETRACE TX SOFTWARE

Model Number 129544

Device Problems Use of Device Problem (1670); Installation-Related Problem (2965)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

Haemonetics received an fda inquiry on march 1, 2023 requesting an mdr be submitted regarding customer medwatch 5113776.There was no adverse event/harm to a patient and no serious or important medical event attributed to an adverse event.Although the reporter asked to remain anonymous, based on a previous complaint, we believe we know the customer and have been working with them diligently to resolve any safetrace tx issues they are having.The client had upgraded to version 4.5.0 in november of 2021 from version 3.4.1.Upon investigation, it was discovered that the client had previously reported this issue to haemonetics in may of 2021 on safetrace tx version 3.4.1.In both cases it was discovered that the client had created a new compatibility code in the cd compatibility (version 4) or compatibility maintenance (version 3) tables for thawedffp and added the new compatibility code to the standard product class tables.However, they did not configure the new code in the compatibility attributes tables.The compatibility attributes table determines which blood attributes of a patient and product are compatible for each compatibility code.This allowed thawed plasma product to be selected for a patient without a factor posting.Haemonetics customer support discussed the missing configuration in the compatibility attributes table in version 3.4.1 with the client when the issue was originally reported in may of 2021.When the problem was reported a second time in version 4.5.0, customer support was given permission to end date the thawedffp compatibility code and update the product codes in the standard product class table to an appropriately configured code already present in the client's system.

Manufacturer Narrative

The investigation shows configuration changes were not properly validated by the customer prior to use in a production setting.This error allowed a client user to product select an incompatible thawed ffp product in safetrace tx version 4.5.0.This error was discovered prior to use in a procedure; therefore, no patient was involved.The warning table was updated on dec 16, 2022 so that there would be a warning message and a requirement for an override if this situation were to reoccur.Common standard operating procedures require multiple checks of blood type by healthcare professionals prior to a patient procedure to minimize the risk of transfusing incompatible blood product.Configuration issues begin with the customer incorrectly configuring their tables and subsequently not performing full validation to ensure the table configuration was correct for their sop's.Haemonetics provides clients several training options on the system including a four-day intensive configuration class for safetrace tx version 3 and version 4.Additionally, there are numerous locations in both our version 3 and version 4 labeling which warn that configurations must be thoroughly tested and validated by the customer before moving to production.These tables must remain configurable to allow a variety of customers to utilize safetrace tx effectively and safely for their patient population.The application has system caches in place to improve performance, and the application server caches all configuration data.Due to this system caching, when configuration changes are made, the changes might take a while to become effective.To address these delays, configuration changes should be performed outside of production hours to allow the changes to take effect.In cases where a quick configuration change is required, manually refresh the appropriate caches once the change is made to ensure that it has been applied throughout the system.Customers are responsible for ensuring that effective configuration training is provided to their users, configuration changes are properly validated and are in accordance with applicable regulations and standards.

• Brand Name: SAFE TRACE TX
• Type of Device: SAFETRACE TX SOFTWARE
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 16682788
• MDR Text Key: 312715526
• Report Number: 1219343-2023-00005
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 129544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1