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

Model Number PCS-300-US

Device Problem Smoking (1585)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in the incident.A haemonetics field service engineer evaluated the device, replaced dc/ic/ui and pneumatic board.Issue was fully resolved, device meet all specifications and was ready for use.The defective part was returned to haemonetics for evaluation, based on evaluation there was a burnt mark on ic board which connects to compressor manifold.

Event Description

On (b)(6) 2020 haemonetics was notified of smoke coming from the nexsys pcs system.Customer also noted that burnt marks were found on the dc/ic pcb and ribbon cable which connected ic pcb to the to the pneumatic compressor of the nexsys pcs system.

• Brand Name: NEXSYS PCS
• 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: 10534719
• MDR Text Key: 206951393
• Report Number: 1219343-2020-00078
• 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: 07/28/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• 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