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U.S. Department of Health and Human Services

Class 1 Device Recall VOLUMAT MC AGILIA US

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  Class 1 Device Recall VOLUMAT MC AGILIA US see related information
Date Initiated by Firm June 24, 2019
Create Date August 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-2064-2019
Recall Event ID 83138
510(K)Number K121613  
Product Classification Pump, infusion - Product Code FRN
Product VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a

Product Usage:
The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics and neonatal human patient to administer via a single channel or mounted on a multiple channels rack accessory: Intermittent or continuous delivery of parenteral fluids (solutions, colloids, parenteral nutrition) and medications (including but limited to diluted drugs, chemotherapy) through clinically accepted IV routes of administration). Transfusion of blood and blood derivatives products. Note that for transfusion procedures, use of a special administration set is required. Volumat MC Agilia can be used with the Dose Error Reduction Software (DERS) Vigilant Drug Lib to define the default and upper hard limits for the Bolus Volume, or dose, by drug. The health care professional can then operate the pump for that drug within the upper hard limits defined in the Drug Library.
Code Information All serial numbers distributed in the US
Recalling Firm/
Manufacturer
Fenwal Inc
3 Corporate Dr Ste 300
Lake Zurich IL 60047-8930
For Additional Information Contact
800-333-6925 Ext. 3
Manufacturer Reason
for Recall
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm initiated the recall by letter on 06/24/2019. The letter describes the issues and provided supplemental instructions to be implemented until the new software is installed.
Quantity in Commerce 9461 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = FRESENIUS KABI AG
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