MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO. 06002-CP-110

Model Number 06002-CP-110

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

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Nausea (1970); Discomfort (2330); Diaphoresis (2452); Movement Disorder (4412)

Event Date 10/17/2021

Event Type  Injury  

Manufacturer Narrative

The center was notified of the event by donor's significant other.The cause of the stroke is unknown as donor's medical records are not available.The center is recommending permanent donor deferral given the new health event and underlying risk factors which render her inappropriate for continued donations.The center has not received any additional information and no further request from the center will be made.Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Haemonetics field service engineer inspected the device and found all configurations met manufacturing specifications.The disposables were not returned, however, there were no recall or adverse trends associated with the product lots used in the procedure.There is no evidence to suggest that the adverse event was related to the device or disposables used during the plasmapheresis procedure.

Event Description

On (b)(6) 2021, haemonetics was notified a donor adverse event occurred.On (b)(6) 2021, the donation center reported a (b)(6) female reported being evaluated and treated for a stroke approximately two hours after her last donation procedure utilizing the pcs®2 plasma collection system.The donor complained of a new right side body paralysis after waking up from a nap after the donation procedure on (b)(6) 2021.Donor complained of nausea and diaphoresis and bowel discomfort during the donation which led to early disconnect per donor request and failure to return rbcs and procedural saline.Symptoms resolved with supportive care, bowel movement and close monitoring.She was able to leave the donation center accompanied by her significant other.Vitals showed elevated bp during the event.The center was notified that the donor was transported to hcs-mainland for further evaluation.Donor was admitted to icu and underwent ct brain and tpa for suspected cerebral vascular event through ct brain non-specific for clear thromboembolism.Center mos was in contact daily with the donor and significant other to obtain status and was informed that the donor was recovering and was discharged home on (b)(6) 2021.There were no issues noted with the equipment or disposables used during the donation procedure.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO. 06002-CP-110
• 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: 12844044
• MDR Text Key: 285766035
• Report Number: 1219343-2021-00141
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040025
• 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: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/1997
• 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; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 156 KG