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

Model Number 07-006

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of teg system and disposables is pending.Haemonetics will provide additional details when investigation is complete.

Event Description

On november 11 2020, haemonetics was notified of false test results, which occurred post procedure utilizing the teg system in denmark.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
• Type of Device: CUPS & PINS, HEPARINASE
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 10982361
• MDR Text Key: 220727154
• Report Number: 1219343-2020-00131
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 20812747018132
• UDI-Public: (01)20812747018132()HMO4809
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K002177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 07-006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: No
• 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