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 12/14/2017

Event Type  malfunction  

Event Description

On (b)(6) 2017 haemonetics was made aware of a plasma donation procedure which was not completed due to ac depletion while using a pcs®2 plasma collection system.The incident occurred (b)(6) 2017.The customer has requested replacement components to replace the ac pump assembly on the machine.The customer's on site technician will perform the device evaluations and repairs prior to returning the machine to service.Follow up with the customer has indicated that the donor did not experience any signs or symptoms of an adverse reaction to the anti coagulant administered.The donor left the center in good health without requiring any medical intervention.

• 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: 7186007
• MDR Text Key: 97098091
• Report Number: 1219343-2017-00037
• 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: Repair
• Type of Report: Initial
• Report Date: 01/12/2018

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: 12/18/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1