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

Model Number 06002-110-NA

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Donor reported to be diagnosed with a blood clot and high cholesterol.An on-site technician evaluated the pcs®2 device in order to check for any faults, the machine was found to meet specifications and did not have any defects which required repair.There was no evidence of a device malfunction found.

Event Description

On (b)(6) 2019 haemonetics was notified of an adverse reaction which had occurred following the plasma donation procedure, utilizing the pcs®2 plasma collection system.The plasma collection procedure was completed successfully, with no error messages or alarms encountered.The pcs®2 plasma collection system collected the target volume of 880ml of plasma and 500ml of saline administered per the routine procedure.Upon disconnecting the donor from the pcs®2 plasma collection system the donor experienced a possible stroke and was transferred to a hospital.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO. 06002-110-NA
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 9896336
• MDR Text Key: 185673958
• Report Number: 1219343-2019-00027
• 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: 06/19/2019

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?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• 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: 45 YR
• Patient Weight: 111