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 Cardiac Arrest (1762)

Event Date 03/09/2024

Event Type  Death  

Event Description

On march 11, 2024, customer made haemonetics aware that a 64-year-old male donor passed away on (b)(6) 2024 from cardiac arrest, believed to have occurred in the hospital according to the obituary.It is unknown if an autopsy was performed.The customer has no information from the attending physician, surgeon, hospital representative or health care professional.A center employee reporting seeing on facebook that the donor went into cardiac arrest on (b)(6) 2024 sometime after leaving the center after his last donation.His chart was reviewed and showed donor completed the donation on (b)(6) 2024 at 18:37; the collection was completed without any issues or adverse events.The donor had no known allergies or pre/post immunizations.The donor donated 15 times in the past 12 months.This donor had no previous procedure related deferrals.The donor did not experience a reaction/adverse event during the procedure.There were no errors with the machine or issues with the disposables noted during the march 1, 2024 procedure.Given the circumstances (natural hospital death >24 hours after admission, not reported to or investigated by the coroner), hospital record request restrictions (family members only) and indiana laws regarding who can obtain a death certificate, the customer is not expecting any more information regarding this event.Donor reported a history of hypertension.Donor was taking amdolpine and atenolol within 72 hours of donation.Pre-donation vital signs and blood values: b/p: 124/70; pulse: 70 bpm; temperature: 97.6f; hct: 46%; total protein: 6.7 g/dl.

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.No issues were found.All parameters were verified.Function tests completed.The machine meets the manufacturer's specifications and is ready to use.The fse did not find any error with the device.The device was evaluated with no defect.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.

• 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: 18950754
• MDR Text Key: 338255155
• Report Number: 1219343-2024-00006
• 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
• Report Date: 03/21/2024

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: 03/11/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/1999
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 76 KG