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

Model Number PCS-300-US

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Pain (1994); Discomfort (2330)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

No donor information provided.Haemonetics was unable to determine the source of this reported incident from the medwatch report provided, without the source details haemonetics is unable to obtain any other information.Based on the information provided haemonetics was also unable to identify which plasma center donor was referring to.

Event Description

On (b)(6) 2021, haemonetics was notified via medwatch report mw5102863 of a donor experiencing pain in both shins, chest pains, headaches and diarrhea during a donation procedure, utilizing the 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: 12530678
• MDR Text Key: 273323953
• Report Number: 1219343-2021-00125
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK180185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other