Medfusion 3500 and 4000 Syringe (2020-08-20)

Starting date:

August 20, 2020

Posting date:

September 1, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73839

Last updated:
2020-09-01

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  Reason
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  Affected products

Affected Products

Medfusion 3500 and 4000 Syringe

Reason

Smiths Medical became aware of an unanticipated behavior in certain Medfusion 3500 and 4000 Syringe Pumps. If a bolus or loading dose is interrupted and a specific sequence of events occurs, inappropriate delivery (over or under-delivery of a bolus or loading dose) may occur. This issue has only been seen at two facilities in the United States.

Affected products