MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS®2 PLASMA COLLECTION SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 06002-CP-110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 haemonetics was notified of an ac depletion incident which occurred that day during a plasma collection procedure on the pcs®2 plasma collection system.The center reported that the donor did not experience a citrate reaction, they did not require medical intervention to prevent injury and the donor left the center that day in good health.Haemonetics has provided the customer with a replacement pump assembly to be installed by the center technician.The device was removed from service until the center technician has replaced the pump assembly and tested the device prior to ensure it meets manufacturing specifications prior to being returned to service.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 7205901
• MDR Text Key: 98171853
• Report Number: 1219343-2018-00001
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK920039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/19/2018

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: Phlebotomist
• Device Model Number: 06002-CP-110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1997
• 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