MAUDE Adverse Event Report: FENWAL, INC. AMICUS SEPARATOR SYSTEM; AUTOMATED BLOOD CELL SEPARATION

Model Number 4R4580

Device Problems Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243)

Event Date 03/14/2014

Event Type  Injury  

Event Description

The pt is undergoing tpe procedures due to a rejected kidney transplant.This same pt has undergone approximately 10 tpe procedures on the amicus device.For this particular procedure, the operator changed the target fluid balance from 100% to 90% after 550ml of whole blood (wb) processed.The operator further adjusted the target fluid balance from 90% to 80% within minute of the first adjustment.An 80% target fluid balance equates to leaving the pt hypovolemic by 20% of their total blood volume.The pt has peripheral access and was showing signs of inlet line occlusions.It is likely that the operator intended to change the maximum wb flow rate, but changed the target fluid balance instead.The machine did as instructed by the operator and targeted 80% for fluid balance which led to this incident.The nurse told the fse that it was very long day and this procedure as around 7 pm, so she was very tired.The pt fainted at the end of the procedure, he had a blood pressure at that moment of 65/40.The treatment the nurse gave was a saline solution bolus of two units (total 1000ml) with a recovery blood pressure of 90/48.After recovery the person left the hospital asymptomatic.It has been difficult for fenwal's risk mgr to speak directly to the pt; however, the nurse spoke to his wife and she stated he is fine and will go to the next scheduled total plasma exchange (tpe) treatment on the amicus machine because he trusts the amicus.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AUTOMATED BLOOD CELL SEPARATION
• Manufacturer (Section D): FENWAL, INC.; 4300 godding hollow pkwy; frederick CO 80504
• Manufacturer Contact: robert popp, dir ; three corporate drive; lake zurich, IL 60047 ; 8475505703
• MDR Report Key: 3736082
• MDR Text Key: 4278200
• Report Number: 3004548776-2014-00002
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: K111702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4R4580
• Device Catalogue Number: 4R4580
• Other Device ID Number: D1206M4599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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): Life Threatening