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Recall Observatory FDA recall evidence

Device 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.

Z-2064-2019

June 24, 2019

Class I

Product summary

Firm
Fenwal Inc
Event
Event 83138
Status
Terminated
Classification
Class I
Quantity
9461 units
Official record key
device-enforcement:Z-2064-2019

Official wording

Reason: 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

Code information: All serial numbers distributed in the US

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomalies

Field note

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