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

Model Number PCS-300-US

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 02/20/2020

Event Type  malfunction  

Manufacturer Narrative

Customer has not responded to the incident.However a field service engineer was dispatched and replaced ic dc mc board, replaced power supply input cable.Device needs new right and left donor display lights.Device also needs a new cuff compressor.Field service engineer will install the remaining parts.

Event Description

On (b)(6) 2020 haemonetics was informed by the customer of a device malfunction resulting in smoke coming out of the machine.

• Brand Name: NEXSYS PCS, US
• 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: 9862352
• MDR Text Key: 184349574
• Report Number: 1219343-2020-00023
• 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: 02/20/2020

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: 02/20/2020
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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