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 Problem Cardiovascular Insufficiency (4445)

Event Date 10/08/2022

Event Type  Death  

Manufacturer Narrative

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 haemonetics field service engineer (fse) performed a full function check on the machine and found it met manufacturer specifications and was ready for use.Per fse evaluation, could not duplicate any error or issues with device.Evaluation conclusion is the device operates as intended and did not contribute to reported complaint.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 were no equipment errors or issues with the disposables noted during the donation.There is no evidence to suggest that the donor fatality was related to the device or disposables used during the plasmapheresis procedure.

Event Description

On october 13, 2022, haemonetics was notified of a 61-year-old male donor fatality which occurred on (b)(6) 2022 from cardiac arrest as reported on the death certificate.Donor has donated plasma since (b)(6) 2019 and donated 2 times in the past month, 57 times this year and 216 times in his lifetime.Donor' s last donation was on (b)(6) 2022 and no significant information or reactions were noted during donation.Review of chart by the center noted history of a normal physical exam and no medical problems except a history of a covid-19 infection.Review of vitals were normal on date of last donation, and he had one out of range temperature of 100.1 f on (b)(6) 2021.His other vitals while at the center were normal.The donor was not on any medications.Failed screening tests include the following: abnormal total proteins of 5.8, 5.8, 5.7, 5.9 and 5.9 g/dl on (b)(6) 2022, (b)(6) 2021 respectively.Donor had deferrals for the following: 6 abnormal serum total proteins, 5 out of limit total proteins, 1 for lapsed donor, 1 for out of limit temperature and 1 permanent deferral due to expiration.There were no medical incident reports received by the center.There were no device errors or issues with the disposables noted during the donation.No further information is expected from the donation center regarding this event.

• 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: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 15722523
• MDR Text Key: 303023024
• Report Number: 1219343-2022-00048
• 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: Consumer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/13/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Device Lot Number: 18E064SPG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 114 KG