MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 SYSTEM; PCS2,LIST NO,LN06002-110-NA

Model Number 06002-110-NA

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

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

Event Date 02/15/2024

Event Type  Death  

Event Description

A 43-year-old female donor was reported to have passed away on (b)(6) 2023 at her home of an asthma attack, the day after a plasmapheresis procedure.The customer obtained this information from her significant other who is also a donor.The customer has no information regarding the treating attending physician, surgeon, hospital representative or health care professional.The donor's last donation occurred on (b)(6) 2024; there were no errors on the machine and no issues with the disposables at the time of the donation.The donor completed a successful donation with no reported collection exceptions or alarms/alerts.The donor did not have a reported reaction during the (b)(6) 2024 donation.Donor had donated 84 times in the past 12 months.

Manufacturer Narrative

A haemonetics field service engineer evaluated the equipment used during the donation.No problem was found.All other parameters verified.Function tests completed.Machine meets manufacturer's specifications and is ready to use.Based on this description the device is evaluated with no defect.There are no nonconformances against the device serial number and no capas related to this complaint.A review of the dhr shows no issues during manufacturing and all testing passed.The disposables used with the system were discarded, 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 event was related to the device or disposables used during the plasmapheresis procedure.

Event Description

Customer reported: based on documentation received from the (b)(6) me's office, the cause of death was "acute alpha-pihp intoxication." contributory causes were "acute bronchial asthma with chronic asthmatic bronchitis." the manner of death was "accident." medical examiner report was forwarded to the fda on 03/27/24.The fda donor death case# is (b)(4).

Manufacturer Narrative

Customer received information from the medical examiner.

• Brand Name: PCS2 SYSTEM
• Type of Device: PCS2,LIST NO,LN06002-110-NA
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston
• MDR Report Key: 18895668
• MDR Text Key: 337567380
• Report Number: 1219343-2024-00005
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK920039
• 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,Followup
• Report Date: 04/30/2024

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-NA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2006
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 180 KG