MAUDE Adverse Event Report: HAEMONETICS CORPORATION NEXSYS PLASMA COLLECTION SYSTEM; PCS-300-US

Model Number PCS-300-US

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

Patient Problem Insufficient Information (4580)

Event Date 11/05/2023

Event Type  Injury  

Event Description

Donation center reported to haemonetics on november 16, 2023, that a 48-year-old female donor finished the plasmapheresis procedure on (b)(6) 2023 but was unable to get all of her blood cells returned back to her.Donor was given a powerade and went to the center's recovery area.While in the recovery area, donor was observed slumped over.Center medical staff attempted to get vitals, but was unable due to donor having involuntary movements.Veins were found unsuitable for manual infusion of saline.Emt's were called.Donor was taken to the hospital.The center was contacted on december 5, 2023 by haemonetics to obtain additional information on donor's condition when it was reported that the donor declined to give any update on information from the hospital.There were no machine errors or issues with the disposables reported at the time of the november 5, 2023 donation.No further information is expected regarding this event.

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.No problem was found.All calibrations, diagnostics and a functional test was performed with no issues.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.Root cause could not be determined as no defect was found.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 issue was related to the device or disposables used during the plasmapheresis procedure.

• Brand Name: NEXSYS PLASMA COLLECTION SYSTEM
• 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: 18282973
• MDR Text Key: 329944093
• Report Number: 1219343-2023-00022
• 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: 12/07/2023

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: 11/16/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 53 KG