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

Model Number 06002-110-EXP-EW

Device Problem Increase in Pressure (1491)

Patient Problem Hemolysis (1886)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Haemonetics field service engineer evaluated the pcs2 plasma collection system, the cuff pressure was found to be high.The cuff was calibrated and pressure issue was resolved.The sample was not returned to haemonetics for evaluation, root cause could not be determined.

Event Description

On (b)(6) 2020, haemonetics was notified of a suspected hemolysis event utilizing the pcs2 plasma collection system.Patient status is unknown as haemonetics was unable to obtain additional information from customer.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: PCS2,LIST NO,06002-110-EXP-EW
• 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: 10991230
• MDR Text Key: 220966712
• Report Number: 1219343-2020-00132
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 30812747011970
• UDI-Public: (01)30812747011970
• 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: 11/11/2020

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-EXP-EW
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2014
• 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