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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 10/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, haemonetics was notified of an adverse event involving a 65-year-old male which occurred during a plasma donation on (b)(6) 2022 utilizing the nexsys plasma collection system.The donation began at 13:57 following a successful venipuncture.At 14:56, a phlebotomist approached the donor because the plasmapheresis machine had alarmed indicating a possible high pressure return situation.The phlebotomist adjusted the needle and inspected the filter for clots.After the needle adjustment, the donation process continued.At 15:00, the donor reported to another phlebotomist that he was not feeling well.The phlebotomist administered comfort care measures which included elevation the donor's feet and applying ice packs.The donor did not disclose any symptoms other than feeling "weird".After two minutes of comfort care, the door reported feeling better.The donor was on his last return and received 500 ml of saline.At 15:06, the donor got up from the bed and walked out of the center.Video footage from the parking lot showed the donor may not have been feeling well during his walk toward the vehicle.He was observed to have stopped and put his hands on his knees on two occasions.After he arrived at his truck, the donor lost consciousness.A dct and two donors witnessed the donor falling to the ground and went to assist him.The center medical staff were summoned in the parking lot and attempted to awake the donor but were unsuccessful.At 15:09, the medical staff were unable to definitively identify the donor's pulse and initiated cpr.After two cycles of cpr, the donor regained consciousness but was disoriented.At 15:14, ems arrived, and the donor was transported to the hospital for further evaluation.The donor returned to the center on (b)(6) 2022 and indicated that he was discharged the day after the event.The donor also provided a hospitalization summary for review.The summary indicated that the final diagnosis was vasovagal syncope.In addition, the summary listed medical conditions not previously disclosed by the donor.Based on all of the available information, including the medical records from the donor's hospital evaluation, the most likely cause of the donor's loss of consciousness was severe hypotension which could present with a weak pulse, loss of consciousness and bradypnea (abnormal slow breathing rate), mimicking cardiac arrest.These symptoms prompted the staff to act quickly and initiate cpr for two cycles after which the door gained consciousness and recovered without further incident.The hospitalization summary revealed that he has a history of long qt interval and left posterior fascicular block which suggests some level of underlying cardiac disease which could have contributed to his signa and symptoms.However, this information was not disclosed to the center staff during his initial donor eligibility evaluation.The donor had no previous donor deferrals applied in the center's system.It is believed that during the donation the day of the major event, the donor did have multiple no flow and high pressure return messages throughout the procedure.Donor disclosed allergies to dust, sagebrush, and some pollen.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.

Manufacturer Narrative

On october 19, 2022, a haemonetics field service engineer performed diagnostic testing on the machine used during the donation and all tests passed.Device was found to be operating within manufacturer's specifications.The device was manufactured according to approved procedures and met all specifications for release.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 event was related to the device or disposables used during the plasmapheresis procedure.

• 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: 15758897
• MDR Text Key: 303307712
• Report Number: 1219343-2022-00050
• 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: 10/14/2022

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
• Device Lot Number: 18J546SPG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male