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 09/26/2022

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.The haemonetics field service engineer that evaluated the machine noted no issues were found and device passed functional testing and meets manufacturer specifications.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 september 28, 2022, haemonetics was notified of a 57-year-old male donor fatality on (b)(6) 2022 from an apparent heart attack as communicated to the donation center by his wife.During plasma donation on (b)(6) 2022, donor started to seize and was immediately attended to by the center staff including physician substitutes.Cpr was provided and ems called.Ems transported the donor from the center.Later his wife called to report that he had a heart attack and passed away.Review of nexlynk information shows that donor used to donate plasma at opi in 2012 and then returned on (b)(6) 2022.He was deferred that day for insufficient veins and asked to hydrate and return in a week.Donor started donating on (b)(6) 2022.He donated 8 times with intervals of 2 to 5 days from (b)(6) 2022 to (b)(6) 2022.Pure plasma collected each time was ~1000 ml and no issues were noted with the donations.No issues with vitals, test results, questionnaires or physical examination were noted.All parameters were within acceptable limits for plasma donation since donor started donating on (b)(6) 2022 and on last donation date of (b)(6) 2022.The only parameter that although is an acceptable weight, was 330 lbs average and is of obese class iii bmi.It is unclear at this time whether obesity played a factor in donor suffering a cardiac event.It is unknown if an autopsy/medical examiner report will be made available.There were no device errors or issues with the disposables noted during the donation.

• 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: 15649876
• MDR Text Key: 302173341
• Report Number: 1219343-2022-00045
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCS-300-US
• Device Lot Number: 18C642SPG
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/28/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 151 KG