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

Model Number PCS-300-US

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

Patient Problems Dyspnea (1816); Nausea (1970); Hot Flashes/Flushes (2153); Dizziness (2194); Numbness (2415); Loss of consciousness (2418); Pallor (2468)

Event Date 10/10/2023

Event Type  Injury  

Event Description

On (b)(6), 2023, haemonetics was notified of a donor that began experiencing symptoms during subsequent cycles of the procedure, at this point 514ml of plasma had been completed and approximately 110ml of saline had been administered.Donor was reported to be experiencing cramping, difficulty breathing, cold extremities, pallor, sweating, dizziness/lightheadedness, numbness/tingling, nausea, as well as loss of consciousness which lasted approximately 3 seconds.Medical staff at the center was notified to provide treatment and ems was contacted.Medical staff attempted to administer saline manually via a peripheral iv as initial needle had been removed, but iv could not be successfully placed.As donor reaction began to subside, oral fluids were able to be given.Upon ems arrival, donor was transported to a local emergency department.The center does not know what might have caused the donor to experience these symptoms, but the donor did state that he had not eaten since 1:30am and the reaction occurred around noon.Follow-up attempts with the donor which occurred the day following the reaction were unsuccessful.Medical operations supervisor at the center reported that donor has returned to the center since reaction occurred but has not attempted to donate.Medical operations supervisor also stated that donor has not disclosed that he required hospitalization.Center staff confirmed that during the donor reaction, the pcs-300 collection system was operating properly without issue.

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.Device passed all diagnostics and functional tests without issues.The device meets the specifications required by the manufacturer.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-conformance's or capas that would have contributed to the reported incident.The status of the disposables used with the system is unknown, however there were no recalls or adverse trends related to the product lots used in the procedure.There is no evidence to suggest that the donor reaction was related to the device or disposables used during the plasmapheresis procedure.

• Brand Name: NEXSYS PCS, US
• Type of Device: PCS-300-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: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 18131830
• MDR Text Key: 328058502
• Report Number: 1219343-2023-00017
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 98 KG