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

Model Number PCS-300-US

Device Problem Computer Software Problem (1112)

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

Event Date 12/19/2020

Event Type  malfunction  

Manufacturer Narrative

Haemonetics confirmed software change that caused the issue, 1.4.0 nexsys software.All customer sites with this version of software were notified and provided a training guide to determine defect.Haemonetics also conducted code review and recreated the issue in a test environment.An update to the software code was implemented at all customer sites that were effected.

Event Description

On (b)(6) 2021 haemonetics was notified of three target volumes above the 100ml threshold with persona utilizing the nexsys pcs system.This was discovered when reviewing a procedure report used in the opi's qa system.There was no reported impact to patients' health.

• 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: 11216736
• MDR Text Key: 229078154
• Report Number: 1219343-2020-00161
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2021

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
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/22/2021
• 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