MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG ANALYZER; TEG ANALYZER, 5000, 60HZ, FG

Model Number	07-022
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being sent as part of a service record retrospective review that was self identified by haemonetics.The reported event indicated a potential thermal event of teg device emitting smoke from where channels are connected.Fse discovered a short in the sample bulb.Eliminated the problem.Unit meets manufacturers specification.Although no property or personal injury has been reported on these type of events haemonetics historically conservatively reports on all thermal events.
Event or Problem Description
Haemonetics was notified that a customer reported a teg device is emitting smoke from where channels are connected, customer needs fse for repair and this was happened after the pm has done on that device.There was no donor involvement.

• Brand Name: TEG ANALYZER
• Common Device Name: TEG ANALYZER, 5000, 60HZ, FG
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11843483
• Report Number: 1219343-2021-00048
• Device Sequence Number: 3846676
• Product Code: JPA
• UDI-Device Identifier: 30812747018184
• UDI-Public: (01)30812747018184
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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
• Operator of Device: Health Professional
• Device Model Number: 07-022
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1