MAUDE Adverse Event Report: FENWAL, INC. AMICUS SEPARATOR SYSTEM

Model Number 4R4580

Device Problem Failure to Calibrate (2440)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

The customer reported the right cassette and plasma waste container began filling with red blood cells (rbc's) within the first four minutes of operation.The procedure was immediately halted and the operator called the technical support hotline.The condition was attempted to be cleared by checking the disposable.The procedure was resumed with the same results.The procedure was discontinued after a total collection time of 7 minutes and 15 seconds.Another procedure was immediately started with a new disposable kit.The customer called back to inform the technical support hotline that the second procedure was running fine.There was no patient reactions or injury reported for either procedure.

Manufacturer Narrative

The plasma waste container should be evaluated for rbc content any time rbcs are noted or there is the presence of red-tinged fluid in the plasma waste container.For the procedure in question, the interface system failed to fully calibrate due to an alarm condition that occurred during the calibration sequence.Upon beginning the procedure, the operator noted the rbc's in the right cassette and plasma waste container.Per the instructions and training on the amicus separator, the operator immediately halted the procedure once rbc's were observed and the procedure was terminated shortly after.A second procedure was started without incident.Rbc's in the right cassette and plasma waste container is not uncommon and is part of the risk profile of the system.There were no patient reactions or injury reported with this event.This is the first confirmed occurrence of this specific issue resulting in rbc's observed by the operator in the right cassette or plasma waste container.Fenwall will continue to monitor field performance for this specific condition as it related to rbc's in the right cassette or plasma waste container.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS SEPARATOR SYSTEM
• Manufacturer (Section D): FENWAL, INC.; three corporate drive; lake zurich IL 60047
• Manufacturer Contact: vanessa labuy, quality assurance ; three corporate drive; lake zurich, IL 60047 ; 8475505640
• MDR Report Key: 4316107
• MDR Text Key: 5207111
• Report Number: 3004548776-2014-00003
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4R4580
• Device Catalogue Number: 4R4580
• Other Device ID Number: D1403M5095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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