MAUDE Adverse Event Report: HAEMONETICS, INC. TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER; TEG MANAGER

Model Number TGV-2739

Device Problem Computer Software Problem (1112)

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

Event Date 11/07/2021

Event Type  malfunction  

Manufacturer Narrative

The tas database in use at the facility had in total (b)(4) tracings and had been in use for over a year (it was created on 10/14/2020).Prior to the creation of that database, an it administrator at the facility had been archiving and creating a new database on roughly a monthly basis.After the it administrator left the position, database archival was no longer being performed.The large size of the database could have contributed to the teg manager agent incorrectly reading from the tas patient database to retrieve the calculated inhibition/aggregation results for a teg 5000 result.It was not able to be proven that this was the root cause of this issue during testing, however from haemonetics analysis, it is believed that the database size played a big role in causing this event.In order to reduce the chance of a large database leading to issues with erroneous results, customers need to be diligent about compacting and archiving their tas patient database on a regular basis.Implementing a warning message into the teg manager agent that alerts the end user when the database needs to be archived will help reduce chances of a large database leading to erroneous inhibition/aggregation test results.Improving labeling to inform customers on the need for database compacting/archiving could also help raise awareness of this issue.

Event Description

On november 19, 2021, haemonetics was made aware of a customer complaint describing an instance where the adp inhibition/aggregation for a teg 5000 plateletmapping adp cluster displayed incorrectly in teg manager.The plateletmapping adp inhibition/aggregation displays correctly in tas.The medical director at the user facility initially noticed the discrepancy when reviewing the result in teg manager.The physician was not aware of any treatment given to the patient based on the erroneous result and there was no reported harm or injury to the patient.

• Brand Name: TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER
• Type of Device: TEG MANAGER
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 12979757
• MDR Text Key: 285758686
• Report Number: 1219343-2021-00152
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

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
• Device Operator: Health Professional
• Device Model Number: TGV-2739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/10/2021
• 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