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

Model Number 06002-CP-110

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Shaking/Tremors (2515)

Event Date 12/31/2020

Event Type  Injury  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the pcs®2 plasma collection system.Engineer checked machine and all settings were within range.Unit met manufacturer specifications.Pcs®2 plasma collection system disposable set sample was received for evaluation; evaluation is still in progress.

Event Description

On (b)(6) 2020 haemonetics was notified of a major cardiovascular event that occurred immediately after procedure started, utilizing the pcs®2 plasma collection system.It was reported that the donors arm started to jerk and donor was foaming at the mouth.The center employee was unable to obtain a pulse, so donor was given chest compressions followed by administering an automated external defibrillator.Once donor regained consciousness donor was sent to hospital via ems.Donor spent two days in hospital and is now doing well.

• Brand Name: PCS2 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: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11216684
• MDR Text Key: 230759769
• Report Number: 1219343-2020-00157
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011900
• UDI-Public: (01)30812747011900
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/1996
• 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): Hospitalization; Life Threatening
• Patient Age: 50 YR
• Patient Weight: 78