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

Model Number 06002-110-NA

Device Problem Device Operational Issue (2914)

Patient Problems Nausea (1970); Tingling (2171); Dizziness (2194)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

Customer reported (b)(4) visited site and replaced rotors on machine.No additional information is available at this time.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.

Event Description

On (b)(6) 2017 haemonetics received notification from the customer reporting anticoagulant depletion during a procedure.During the first 15 minutes of procedure, tech noticed the 250ml bag of solution was completely depleted.Tech replaced the empty bag with a new one, bag depleted as well.Nurse intervened and changed machine volume from 825ml to 500ml and ended procedure as donor indicated feelings of "tingles".The healthcare professional administered (b)(6) (antacid made of sugar and calcium carbonate) and juices until donor appeared stable.

• 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 9114
• Manufacturer Contact: christopher bailey-gates ; 400 wood rd; braintree, MA 02184-9114 ; 7813569845
• MDR Report Key: 6904295
• MDR Text Key: 89431407
• Report Number: 1219343-2017-00025
• 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: 09/29/2017

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-NA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/1999
• 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