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Plum 360 infusion system with mednet

Official notice

20 Jul 2023

Last checked

20 Jul 2023

Medium riskHealth Canada
Watch Icu Medical

An official Health Canada notice concerns Plum 360 infusion system with mednet. Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display. Recall start date: July 5, 2023 Published 2023-07-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73967

Official notice

2023-07-20

The hazard

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display. Recall start date: July 5, 2023

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

73967

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Affected products

Product 1

Affected products - Plum 360 Infusion System With Mednet, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 30010

Risk / hazard

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. Alarms on Plum 360 consist of three elements: a visual alarm indication, an audible signal, and a message that appears on the display. Plum 360 pumps test the primary alarm audible signal during the power-on sequence. If the pump detects a failure of the audible signal during power-on, the pump display will remain off and the line b drip indicator will flash, indicating the pump has failed power-on. If the audible signal fails after passing the power-on test and during the use of the pump, a situation may occur where the pump has stopped infusion and an alarm is triggered without an audible signal. The pump will remain in this state until a clinician addresses the alarm. The visual alarm indication and the message will still appear on the display. Recall start date: July 5, 2023

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Icu Medical, Plum 360 Infusion System With Mednet

Manufacturer

Not provided

Phone

Not provided

Brand: Icu Medical, Plum 360 Infusion System With Mednet.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73967

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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