Plum 360 Infusion System with MedNet (2015-10-06)

Starting date:

October 6, 2015

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-55648

• Reason
• Affected products

Affected Products

Reason

When the user selects "yes" at the "new patient?" screen, and the program was not changed prior to powering off the infuser, the distal occlusion pressure setting is assigned a value of 15 psi (775 mmHg) instead of the default value. In addition, the user interface will incorrectly display the default distal occlusion pressure value. The default value is set at 6 psi from the manufacturer. The user would not be immediately aware of the unintended occlusion pressure setting unless the user views the current distal pressure value on the infuser display and it is greater than the distal pressure alarm limit. This may result in delay of therapy related to delay in identifying the occlusion cause.

Affected products