MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PCS®; PCS-300-US

Model Number PCS-300-US

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched and inspected the pcs-300-us machine.The engineer noticed burn marks on the pneumatics manifold and provided customer with a new part.

Event Description

On january 31, 2020, haemonetics was informed by the customer of a malfunction regarding burning smell.

• Brand Name: NEXSYS PCS®
• Type of Device: PCS-300-US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9997874
• MDR Text Key: 188899860
• Report Number: 1219343-2020-00036
• Device Sequence Number: 1
• Product Code: GKT
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/31/2020

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
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• 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