Large-volume infusion pump recalled

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or [email protected].

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or [email protected].

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.

Doctor and patient

Credit: CDC

The medical technology company CareFusion has announced a Class I recall of its Alaris Pump model 8100, software version 9.1.18.

This large-volume infusion pump is used for the delivery of fluids, medicines, blood, and blood products.

Version 9.1.18 of the Alaris Pump model 8100 is being recalled due to the possibility of a software failure in which the pump module will not properly delay an infusion when the “Delay Until” option or “Multidose” feature is used.

There have been no reports of adverse events or deaths related to this malfunction, but it does pose risks. CareFusion has received 1 report where the device malfunctioned when the “Delay Until” option was selected.

The software failure also prevents the pump from properly delivering a multidose infusion under the following conditions:

• When the first dose is programmed to infuse when the system time is earlier than 7 pm and a subsequent dose is intended to infuse between 7 pm and 11:59 pm
• When the first dose is programmed to infuse when the system time is between 7 pm and 11:59 pm and a subsequent dose is intended to infuse between 12 am and 6:59 pm the next day.

If the infusion starts earlier or later than intended and is not immediately detected and stopped, serious injury or death could result. Therefore, healthcare professionals should not use the Alaris Pump module “Delay Until” option or the “Multidose” option.

However, CareFusion said it has identified the root cause of the issue and recommends that the previous Alaris Pump module software version 9.1.17 be installed to address this recall. The company said it will contact all affected customers to schedule the installation of software version 9.1.17.

As an interim guidance, customers may update their dataset to disable both “Delay” options (“Delay Until” and “Delay For”) and/or the “Multidose” option across all profiles to prevent the use of these features. These are shared configurations with the Alaris Syringe module and, if disabled, would prevent use of these features with the Alaris Syringe module as well.

For more information on this recall, see CareFusion’s recall notice, or contact the CareFusion Support Center at 888-562-6018 or [email protected].

To report adverse reactions or quality problems associated with this product, visit the Food and Drug Administration’s MedWatch website.