MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER; TEG ANALYZER, 5000, 230V, 50HZ, FG

Model Number 07-033

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The field service technician inspected the device and replaced all electrical components and columns.The field service technician also performed all functional tests and confirmed that all functions passed.The unit is operating within manufacturing standards.

Event Description

On (b)(6) 2019 haemonetics was informed that during a quality check (qc) a teg analyzr, 5000, 60hz, fg started smoking and turned itself off.The analyzer was then unplugged.A patient was not at the time the event occurred.

• Brand Name: TEG® 5000 THROMBELASTOGRAPH® HEMOSTASIS ANALYZER
• Type of Device: TEG ANALYZER, 5000, 230V, 50HZ, FG
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, MA 02110
• MDR Report Key: 9636263
• MDR Text Key: 181541113
• Report Number: 1219343-2020-00002
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 30812747018184
• UDI-Public: (01)30812747018184
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

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: No Information
• Device Model Number: 07-033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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