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

Model Number PCS-300-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pallor (2468)

Event Date 11/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 at 15:10, machine n58 gave alarm message "air detected in blad".Healthcare professional attempted to troubleshoot alarm, noting multiple air bubbles near donor's vp site.Procedure was discontinued, no rbc's or saline were given to donor.Machine was taken out of service and placed in quarantine at 15:16.Donor voiced feeling well, then while being monitored, voiced feeling nauseous, auditory and visual disturbances and appeared pale.Donor was hypotensive.Ems was contacted at 15:34 and donor was transported to a medical center.Donation center contacted the donor the next day on (b)(6) 2023 and donor stated that he was not given any medications in hospital and that he was feeling fine.He was only there for observation.

Manufacturer Narrative

The pcs300 has redundant systems in place to monitor the flow for air bubbles (it can detect bubbles 0.250 inches long but not detect bubbles 0.120 inches long, and will do so with flow rates from stationary to 200 ml/min) and improper pump rates, stopping the procedure if triggered.This preventative measure makes the chances of the risk very unlikely and outweighed by the benefits of plasma donations.A haemonetics field service engineer performed an inspection of the collection system used in the procedure.No problem was found.Device was checked using the diagnostic and self-test functions.All parameters verified.Function tests completed.Machine meets manufacturer's specifications, and is ready to use.A review of the dhr reveals no issues during the manufacturing process that would contribute to this complaint.The device was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, non-conformances or capas that would have contributed to the reported incident.A root cause could not be determined as the field service engineer could not duplicate any failures in the device.The disposables used with the system were discarded, however there were no recalls or adverse trends related to the product lots used in the procedure.

• Brand Name: NEXSYS PCS SYSTEM
• Type of Device: NEXSYS PCS, US
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 18293352
• MDR Text Key: 330064981
• Report Number: 1219343-2023-00020
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/12/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 84 KG