VAMP Optima, FloTrac sensor VAMP Optima system (2019-03-11)

Starting date:

March 11, 2019

Posting date:

April 5, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69480

Last updated: 2019-04-05

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  Reason
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  Affected products

Affected Products

1. A. VAMP Optima
2. FloTrac Sensor VAMP Optima System

Reason

The instructions for use are unclear in the steps for blood sampling and the positioning of the stopcock. If the clinician were to incorrectly position the stopcock, the blood sample will be diluted with saline. This has occurred with drawing 2 mL samples for blood glucose readings. The clinician immediately noted upon testing the saline in the blood sample. When this occurs, the clinician will need to obtain another pure blood sample for testing. This may cause a slight delay in treatment.

In addition, some clinicians are putting the reservoir stopcock in the incorrect position when flushing after a blood draw. This can result in not clearing blood completely from the top of the reservoir and subsequent clot forming. Clotting is an inherent risk when any device is introduced into the vascular system. Since line maintenance is a routine part of patient care, line clotting is unlikely to result in an injury. If clotting does occur, the clinician can change out the system with a minimal delay in treatment or monitoring.

There is a potential for distortion in pressure readings if the stopcock at the reservoir is in the incorrect position. This is also true for the lass sample site.

Affected products