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Medfusion syringe infusion pumps

Official notice

11 Apr 2022

Last checked

11 Apr 2022

Critical riskHealth Canada

An official Health Canada notice concerns Medfusion syringe infusion pumps. Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery alarms 3. Time Base Alarm 4. Intermittent Volume Over Time (IVOT) - Infusion continues after system fault 5. Clearing of Program Volume Delivered (PVD) 6. False Alarm for Rate below recommended minimum for syringe size 7. Incorrect bolus or loading dose time display 8. Domain Name Server (DNS) port 1001 and when some of these issues happen, It may lead to delay in therapy or interruption of therapy, which may result serious injuries to patients. Recall start date: Mar 28, 2022 Published 2022-04-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64065

Official notice

2022-04-11

The hazard

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery alarms 3. Time Base Alarm 4. Intermittent Volume Over Time (IVOT) - Infusion continues after system fault 5. Clearing of Program Volume Delivered (PVD) 6. False Alarm for Rate below recommended minimum for syringe size 7. Incorrect bolus or loading dose time display 8. Domain Name Server (DNS) port 1001 and when some of these issues happen, It may lead to delay in therapy or interruption of therapy, which may result serious injuries to patients. Recall start date: Mar 28, 2022

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64065

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Affected products

Product 1

Affected Products - Medfusion 3500 Syringe Infusion Pump, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 3500-0600-50, 3500SD-500, 3500VX-500, 3500VX-415, 3500, 3500-415, 3500-306, 3500-414, 3500-500, 3500SD, 3500VX-306

Product 2

Affected Products - Medfusion 4000 Syringe Infusion Pump, Lot or Serial Number - More than 10 numbers, contact manufacturer., Model or catalog number - 4000-0100-51, 4000-0101-50, 4000-0105-51, 4000-0601-01, 4000-0101-295, 4000-0101-95, 4000-0106-00, 4000-0106-01, 4000-0101-78, 4000-0100-50, 4000-0100-295, 4000-0100-95, 4000-0101-51, 4000-0100-249

Risk / hazard

Smiths Medical became aware of eight (8) issues-(identified below) that can potentially occur that may impact therapy delivery in specific Medfusion 3500 and 4000 syringe infusion pumps. 1. Primary Audible Alarm (PAA) 2. Unanticipated depleted battery alarms 3. Time Base Alarm 4. Intermittent Volume Over Time (IVOT) - Infusion continues after system fault 5. Clearing of Program Volume Delivered (PVD) 6. False Alarm for Rate below recommended minimum for syringe size 7. Incorrect bolus or loading dose time display 8. Domain Name Server (DNS) port 1001 and when some of these issues happen, It may lead to delay in therapy or interruption of therapy, which may result serious injuries to patients. Recall start date: Mar 28, 2022

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Smiths Medical Asd, Medfusion Syringe Infusion Pumps.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

64065

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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