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Medfusion syringe infusion pumps
Official notice
11 Apr 2022
Last checked
11 Apr 2022
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
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
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.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Smiths Medical Asd, Medfusion Syringe Infusion Pumps.
Source & status
Source & status
Source
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Category
Classification
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Recall details
Recall details
Recall number
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Documents, notices & source
See the official notice and source documents for full details.
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