MAUDE Adverse Event Report: HAEMONETICS, INC. PCS®2 PLASMA COLLECTION SYSTEM; PCS2, LN, 06002-110-EXS-EW,

Model Number 06002-110-EXS-EW

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

Patient Problems Hemolysis (1886); Hematuria (2558)

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Haemonetics is in the process of completing the investigation.

Event Description

On (b)(6) 2021, haemonetics was notified of "suspected haemolysis" after a donation utilizing a pcs®2 plasma collection system.It was reported a red cell overrun with no alarm occurred, cells were returned to donor and the machine was removed from service.The donor reported to the donation center "red/pink urine when he got home following his donation." no intervention was required and donor was reported to be "fine." there were no errors noted on the equipment and no reported issues with the disposables during the procedure.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2, LN, 06002-110-EXS-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: 13117746
• MDR Text Key: 290281059
• Report Number: 1219343-2021-00159
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120065
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06002-110-EXS-EW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1