MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS SYSTEM; NEXSYS PCS, US

Model Number PCS-300-US

Device Problem Smoking (1585)

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

Event Date 01/24/2021

Event Type  malfunction  

Manufacturer Narrative

There was no donor involved in the incident.Customer requested an ic board replacement.The ic board has yet to be returned to haemonetics, without physical sample provided for evaluation the root cause could not be determined.

Event Description

On (b)(6) 2021 haemonetics was notified of smoke and burning smell on a nexsys pcs system.

• Brand Name: NEXSYS PCS SYSTEM
• Type of Device: NEXSYS PCS, US
• 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: 11336811
• MDR Text Key: 232143767
• Report Number: 1219343-2021-00008
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011659
• UDI-Public: (01)30812747011659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/24/2021

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: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2021
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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