MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2, LN, 06002-110-EXS-EW

Model Number 06002-110-EXS-EW

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  Death  

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.No issues were found.Calibrations were performed and found to be within specification.Functional tests met manufacturing specifications.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.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 death was related to the device or disposables used during the plasmapheresis procedure.

Event Description

On february 20, 2024, the center reported the following to haemonetics: on february 16, 2024, reception technician reported to center manager that she had seen on social media that a 61 year old, male donor had passed away on (b)(4) 2024 post donation from an apparent stroke.The donor had completed a donation at the center on (b)(6) 2024 and left the buidling with no reported issues.The center manager and assistant manager of quality reviewed the donor file and all vital signs, hematocrit and total protein results appeared to be within the normal range for the donor.Interviews were conducted with the reception technician who stated he remembered seeing the donor and stated the screening process was normal and nothing out of the norm was observed.The phlebotomist who had performed the venipuncture and initiated the donation process was interviewed at which time stated the donor seemed in fine health and his normal character.There were no issues with the venipuncture or donation process noted.The donor engaged in small talk about an upcoming vacation.When interviewed, the donor support technician stated he had remembered previous interactions with the donor but did not remember anything specific about disconnecting the donor from the machine on (b)(6) 2024.Cctv footage was reviewed from all interactions in the center with the donor on the day of the procedure and the donor did not seem in distress or uncomfortable at any time while in the center on (b)(6) 2024.There was not any treatment administered at the center since event occurred outside the center, post donation.Donor's death was reported as a stroke.Donor passed away on (b)(6) 2024 at the hospital.The center's area center medical director attempted to request information from the hospital however, the hospital would not release any information.There was no autopsy performed.There were no disclosed allergies or pre/post immunizations.The donor did not have a reported reaction during the (b)(6) 2024 donation.Donor had donated 98 times in the past 12 months.Pre-donation vital signs and blood values: b/p: 148/96.Pulse: 89 bpm.Temperature: 98.0f.Hct: 48%.Total protein: 8.2 g/dl.Gender: male.Age: 61 years old weight 256 lbs.Previous donor: yes.Donor took tylenol and ibuprofen; no other meds reported the donor had one deferral in (b)(6) 2022; he had a reaction on (b)(6) 2022 during his donation; he had loss of consciousness for 10-20 seconds, pale and sweating; by the time the medical staff made it out to the donor floor, he was alert and oriented; the center's medical director approved him to continue donating on (b)(6) 2022.He has not had any other reportable adverse events since donating with the center.There were no errors on the machine and no issues with the disposables at the time of the donation or any issues noted on subsequent procedures.The donor completed a successful donation with no reported collection exceptions or alarms/alerts on (b)(6) 2024.

• Brand Name: PCS2, LN, 06002-110-EXS-EW
• Type of Device: 06002-110-EXS-EW
• 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: 18874760
• MDR Text Key: 337321692
• Report Number: 1219343-2024-00004
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120065
• 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: 03/11/2024

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: 06002-110-EXS-EW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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: 116 KG