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 Problems Dyspnea (1816); Pain (1994)

Event Date 09/10/2023

Event Type  Death  

Event Description

On october 19, 2023, haemonetics was notified of a 49-year-old male donor fatality on (b)(6) 2023 from an unknown cause at an unknown location.The center was notified of the death by the donor's wife.The donor was observed to have had trouble breathing by center personnel and reported chest pain approximately one hour into the procedure.He was then taken out of the center by emergency personnel.The center has no information from hospital personnel regarding cause of death.It is unknown if an autopsy was performed or if a report will be made available.There is no record of any issues with the equipment or disposables used during the procedure.No other information related to the death was uncovered.If additional details in this case are forwarded, haemonetics will submit a supplemental report.

Manufacturer Narrative

A haemonetics field service engineer performed an inspection of the collection system used in the procedure.Standard maintenance tests performed per the manual.Calibrations, diagnostics and functional test performed.Electrical safety deemed passing.There were no issues found with the device.The device was found to have met manufacturer specifications with no malfunction found.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 fatality was related to the device or disposables used during the plasmapheresis procedure.

Manufacturer Narrative

Supplemental mw was submitted as additional information was received from the donation center.

Event Description

Additional information received december 12, 2023: the donor was observed to have had trouble breathing by center personnel and reported chest pain.The procedure started at 11:25am and center medical personnel were called at 12:15pm.Emergency services was called and donor was taken out of the center by emergency personnel and transported to the hospital.There were no machine errors or issues with the disposables at the time of this event.The donor died on (b)(6) 2023.The time of death was 20:33, and he was pronounced dead at 21:21 at his home by a deputy medical examiner.According to the coroner's office and certificate of death, based on the opinion of the investigator and probable cause, the immediate cause of death was acute cardio respiratory failure.The condition leading to the immediate cause of death was emphysema consistent with chronic obstructive pulmonary disease.Tobacco use also contributed to his death.The coroner's office said that it is "unknown" if the donor was seen and discharged or left against medical advice (ama) from the hospital on the day of his death.No autopsy report was completed.The toxicology report was positive for benzoylecgonine (a cocaine degradation product), amlodipine (a blood pressure medication), and cotinine (a nicotine metabolite).Donation center has noted that no further information is expected regarding this event.

• 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: 18152966
• MDR Text Key: 328319941
• Report Number: 1219343-2023-00016
• 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,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 88 KG