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

Model Number 06002-110-NA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

On november 30, 2017 haemonetics received a response from the customer providing additional information regarding the device and procedure.Haemonetics sent replacement pump rotors to the customer site to replace the potentially defective ac pump rollers on the pcs®2 plasma collection system.The defective pump rotors are not expected to be returned for further evaluation.This issue of anticoagulant 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.These chemicals can cause damage to the pump rollers which may lead to a device malfunction.Haemonetics has confirmed that the customer is aware of the haemonetics medical device safety alert regarding the proper cleaning solutions to use to prevent the early degradation of the rollers.

Event Description

On november 27, 2017 haemonetics was made aware of an ac depletion which occurred during a routine plasma donation procedure on the pcs®2 plasma collection system.There were no donor reactions as a result of the ac depletion.The customer has reported that the collection procedure was completed successfully, there was no ac solution remaining within the anti-coagulant bag at the end of the procedure.The donor did not exhibit any signs of a citrate reaction, no medical intervention was required.

• 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: david ramsay ; 400 wood road; braintree, MA 02814 ; 7813487327
• MDR Report Key: 7074483
• MDR Text Key: 94203960
• Report Number: 1219343-2017-00034
• 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: 12/01/2017

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: 06002-110-NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2007
• 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