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

Model Number 06002-110-NA

Device Problem Insufficient Information (3190)

Patient Problems Hemolysis (1886); Nausea (1970); Pain (1994)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer did find the blood pump rotor and ac pump rotor to be worn, which it was then replaced.All other parameters were verified, machine met manufacturer's specifications.The disposables were returned to haemonetics for evaluation, a visual evaluation was conducted and a burr was identified on a section of the y-connector tubing.The results of the evaluation are still pending.

Event Description

On june 17, 2021, haemonetics was notified of a confirmed hemolysis event which had occurred during a donation procedure, utilizing the pcs®2 plasma collection system.During donation procedure donor experienced lower back/flack pain, nausea and facial pallor.Donation was discontinued and all of the red blood cells were returned to donor.There were no errors noted on the equipment during the procedure.Donor was later transported from the center to the hospital.The center did perform a follow up on donors' health status, the results of this follow up are currently unknown.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO. 06002-110-NA
• 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: 12060444
• MDR Text Key: 259985625
• Report Number: 1219343-2021-00047
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011801
• UDI-Public: (01)30812747011801
• 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: 06/17/2021

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-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2006
• 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): Other