MAUDE Adverse Event Report: HAEMONETICS, INC. PCS®2 PLASMA COLLECTION SYSTEM; PCS2,LIST NO,LN06002-110-NA-EW

Model Number 06002-110-NA-EW

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

Patient Problems Cyanosis (1798); Emotional Changes (1831); Pallor (2468)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2022, haemonetics was updated on the medical condition of the donor.Donor informed the donation center that his cardiac mri showed no results.Donor also stated that they would be placing a subcutaneous implantable cardioverter defibrillator.Per the donor, he was diagnosed with pneumonia and a diagnosis as to why the cardiovascular event occurred could not be determined.Donor is no longer in intensive care and stated his vital signs have been within normal limits while being hospitalized and that he is feeling great.The investigation into the equipment and disposables used in the procedure is on-going.

Event Description

On (b)(6) 2022, haemonetics was made aware that a donor had a major cardiovascular event at the end of a donation using a pcs®2 plasma collection system.Donor presented symptoms of cyanosis, facial pallor, loc> 60 seconds, restlessness, shortness of breath and sweating.Cpr and oxygen were administered to the donor at the center.Donor was taken to the hospital and placed in the intensive care unit.The donor did not disclose any prior medical history or any current medications he was taking.There were no reported complications with the donation.There were no reported malfunctions of the equipment or disposables used during the donation.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO,LN06002-110-NA-EW
• Manufacturer (Section D): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS, INC.; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 14406714
• MDR Text Key: 291706697
• Report Number: 1219343-2022-00028
• Device Sequence Number: 1
• Product Code: GKT
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/05/2022

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-EW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2008
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 86 KG