MAUDE Adverse Event Report: HAEMONETICS CORPORATION TEG SYSTEM; KIT, CUPS & PINS, NATURAL

Model Number	07-052
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of teg system and disposables is pending.Haemonetics will provide additional details when investigation is complete.
Event or Problem Description
On (b)(6) 2020 haemonetics was notified of false test results which occurred post procedure utilizing the teg system in (b)(6).At this time there was no reported impact to patients' health, haemonetics is awaiting additional information regarding misdiagnosis and patient impact.

• Brand Name: TEG SYSTEM
• Common Device Name: KIT, CUPS & PINS, NATURAL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 10982238
• Report Number: 1219343-2020-00129
• Device Sequence Number: 11815834
• Product Code: JPA
• UDI-Device Identifier: 20812747018132
• UDI-Public: (01)20812747018132()HMO4809
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K002177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 07-052
• Device Lot Number: HMO4809
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1