MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,06002-110-EXP-EW

Model Number 06002-110-EXP-EW

Device Problem Insufficient Information (3190)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/08/2021

Event Type  Death  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer evaluated the unit and there were no problems found.All settings and parameters were verified, unit met manufacturers specifications.The disposables were discarded by customer, without physical sample haemonetics is unable to establish cause.

Event Description

On june 03, 2021, haemonetics was notified of a donor fatality which occurred within 24 hours of the donor's last plasma donation procedure, utilizing the pcs®2 plasma collection system.Although donation was completed successfully, donor did experience a high pressure return.Post donation donor had experienced a medical emergency in the centers parking lot.The donor was transmitted to the hospital via ambulance where the donor experienced a full cardiac arrest and died the same day.There is no autopsy report available at this time.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO,06002-110-EXP-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: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 12120062
• MDR Text Key: 259974953
• Report Number: 1219343-2021-00084
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/03/2021

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-EXP-EW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Weight: 114