MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF

Catalog Number 07-601

Device Problem Output Problem (3005)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

On november 14, 2022, haemonetics was made aware that "bumps and strange curves on almost every second run we do (sometimes even more)".Customer reported high lysis tracings resembling erroneous ly30 results when using the teg6s citrated: k, kh, rt, ff test analyzer.This event did not occur during a procedure and no patient was involved.Because there is a possibility, although remote, of a mis-diagnosis, it was decided to report this event.

Manufacturer Narrative

The devices have not been returned to haemonetics for evaluation.The root cause of the reported complaint cannot be determined at this time; it is not possible to determine if there was a defect related to manufacturing without a sample for evaluation.The automated teg 6s hemostasis analyzer is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of a patient's hemostatic status and its clinical implications.The teg 6s analyzer is indicated for use with adult patients where a dynamic evaluation of blood coagulation and hemostatic properties is desired.According to the early analysis of the data shared by the customer, the ly30 and ma parameters are affected.Those 2 parameters are used by the practitioner as decision parameters.If used in isolation, erroneous values could lead to misdiagnosis of hyper/hypocoagulable.The product documentation warns against using any parameter in isolation.The ly30 issues that the customer is experiencing is estimated to have a potential impact on the treatment received by a patient.Harm is considered possible but unlikely due to mitigations in place.Also, there have not been any reports of patient mis-diagnosis due to abnormal ly30 readings.Clinicians are provided guidance by haemonetics to not treat according to a single parameter, and to develop a comprehensive treatment plan according to the patients' overall, holistic health.Results from the teg 6s system should not be the sole basis for a patient diagnosis but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, other coagulation tests.In addition, our guidance also instructs the clinicians to establish their own acceptable reference ranges for ck-ly30 and how it aligns with ma.Because there is a possibility, although remote, of a mis-diagnosis, it was decided to report this issue.

• Brand Name: TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF
• Type of Device: TEG 6S HEMOSTASIS SYSTEM CITRATED K, KH, RT, FF
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 15949643
• MDR Text Key: 308153274
• Report Number: 1219343-2022-00056
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K150041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07-601
• Device Lot Number: C420714227, C420718225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1