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

Model Number 06002-110-EXS-EW

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Tightness/Pressure (2463); Patient Problem/Medical Problem (2688)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

Haemonetics received the ac rollers for evaluation.The rollers durometer was measured and found within specification.The rotor was installed on a pcs2 machine and tested with water filled tubing.No volume accounting discrepancy was observed.No root cause of the ac depletion was found.This issue of anticoagulant (ac) depletion has been investigated under a corrective action.The results of that investigation determined the likely cause was the harsh cleaning solution used to clean the pump rollers at the customer site can cause damage to the pump rollers which may lead to a device malfunction.New rotors were sent to the customer for the on-site technician to replace.

Event Description

Haemonetics received a complaint on (b)(6) 2017 on the pcs2 plasma collection system.The customer reported anticoagulant (ac) depletion, with a minor citrate reaction.The ac depleted prior to the end of the procedure, but the donor was administered 500ml of saline and the procedure was completed with 825ml of plasma collected.The donor then complained of transient nausea and tightness/cramping across anterior chest and abdomen.All symptoms resolved within ten minutes and no medical intervention was required.The donor left the center in good condition.

• Brand Name: PCS®2 PLASMA COLLECTION SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6650987
• MDR Text Key: 77877341
• Report Number: 1219343-2017-00011
• 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: Other
• Type of Report: Initial
• Report Date: 05/31/2017

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?: Yes
• Device Operator: Phlebotomist
• Device Model Number: 06002-110-EXS-EW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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): Other
• Patient Age: 30 YR
• Patient Weight: 73