MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM; MCS+ (RBC),LIST NO 08150-110-E

Model Number 08150-110-E

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

Patient Problems Dyspnea (1816); Hot Flashes/Flushes (2153); Loss of consciousness (2418); Diaphoresis (2452); Pallor (2468); Cough (4457)

Event Date 11/07/2022

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2022, a haemonetics field service engineer evaluated the system that was used by the donor.Diagnostics, functional test and visual inspections were performed and all systems passed.The equipment 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 non-conformances or capas that would have contributed to the reported incident.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 fatality was related to the device or disposables used during the plasmapheresis procedure.

Event Description

On (b)(6), 2022, haemonetics was notified of a 72-year-old male donor fatality from an unknown cause.While processing the last return of the procedure utilizing the mcs®+ 8150 multicomponent collection system on (b)(6), 2022, the donor began to cough and appeared flush; donor stated he felt lightheaded.Staff laid the donor back and noticed sweat on his forehead.The donor closed his eyes and said he was having trouble catching his breath.The donor's face was white, he was unresponsive and passed out.Staff began rubbing donor's chest.Staff were unable to find a pulse and began chest compressions.The police arrived and connected the donor to an aed.Ems arrived and they also provided care.The donor could not be resuscitated.The donor was transported to the hospital.Haemonetics requested information from attending physician, surgeon, hospital representative or healthcare professional, but the center has not responded.There were no deferrals on this donation and no eligibility deferrals since 2015.The death certificate has not been provided to the center.An autopsy has been performed; however, the final report is not yet available.Haemonetics will submit a supplemental medwatch report when the autopsy report is received (report should be available 4-6 weeks from the date of the autopsy which occurred on (b)(6) 2022, according to the center).

Event Description

On january 6, 2023, haemonetics was made aware that a 72-year-old male donor cause of death was cardiac arrest per physician who was caring for the patient/donor at the time of his demise.The autopsy demonstrated severe atherosclerosis of the coronary arteries and other findings consistent with his history of long-standing hypertension.The autopsy did not demonstrate any findings that would suggest the donor's demise was due to the apheresis instrument.The kit passed visual inspection.There were three air in line sensor 1 machine alarms during the process.These alarms are not uncommon, not an indication of an equipment malfunction, and are a safety feature meant to alert the operator to trouble shooting appropriately (adjusting tubing and cleaning sensor) to resolve the alarms.This sensor alarm causes the machine to pause the blood flow until the technician can evaluate the system to ensure donor safety.Routine trouble shooting would be to adjust/reinsert the tubing.If alarm continues, then cleaning the sensor is next step.1) 12:25 - air in line sensor 1, tubing adjusted- procedure resumed.2) 2nd alarm for - air in line sensor 1- tubing adjusted - procedure resumed.3) 3rd alarm for - air in line sensor 1- the sensor was cleaned and tubing reinserted - procedure resumed.During procedure staff monitor via the equipment display the reinfusion rate/pressure.Staff noticed dpm (donor pressure monitor) was above normal.Staff followed.Appropriate trouble shooting steps: 1) adjusting machine setting from standard flow rate of 120 ml/min to 40 ml/min.2) inspecting the vp site for infiltration or hematoma - no signs of either.3) reposition donor's arm.4) the pressure monitoring returned to normal range (was corrected) and machine adjusted to flow rate of 80 ml/min.During the collections staff bumped the machine causing a weigher alarm (routine alarm), the alarm was cleared.

Manufacturer Narrative

This is a supplemental report, 1219343-2022-00053-01.

• Brand Name: MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM
• Type of Device: MCS+ (RBC),LIST NO 08150-110-E
• 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: 15904387
• MDR Text Key: 304685483
• Report Number: 1219343-2022-00053
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060065
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG