Important Safety Information on Alaris Infusion Sets and Alaris 8100 Pump Module - Risk of Over-Infusion
- Starting date:
- April 28, 2019
- Posting date:
- April 28, 2019
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices, New safety information, Suspected quality concern
- Audience:
- Healthcare Professionals, Hospitals
- Identification number:
- RA-69764
Last updated:
Audience
Healthcare professionals in hospitals and other healthcare facilities using volumetric infusion pumps
Key messages
- Becton Dickinson (BD) has issued a recall of affected lots (see Products Affected below) on April 18th, of the Alaris Pump Infusion Sets due to a manufacturing defect that can cause unintended delivery which can result in over-infusion. BD has requested Canadian facilities to remove and destroy all affected products and is investigating whether additional lots may be affected.
- While the investigation is ongoing, Health Canada is disseminating this safety information to other potentially impacted healthcare facilities.
- Healthcare professionals should only use Alaris Pump Infusion Sets that have not been identified as part of the affected lots
- As
a precautionary measure, for all other infusion sets, not just those
identified to date, Health Canada recommends that healthcare
professionals:
- During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time.
- Always close the roller clamp when infusion is not intended.
- Ensure the tubing is loaded according to the manufacturer’s instructions.
- Open the roller clamp and verify that no fluid is dripping through the drip chamber before attaching the pump to a patient and initiating an infusion.
- Health Canada continues to monitor the situation and will work with the manufacturer to provide an update if additional affected lots are identified.
Issue
What is the issue?
Health
Canada has received reports of over-infusion with the Alaris Pump
Infusion Sets used with Alaris 8100 Pump Module in Canadian hospitals.
The manufacturer has confirmed that unintended delivery can be caused by
defective Alaris Pump Infusion Sets. Unintended delivery of medications
can cause serious patient injury, depending on the type of medication
which is being delivered.
Unintended
delivery can occur when the pump is in Pause mode, or can also result
in a faster than expected drug delivery rate when the pump is infusing.
The
manufacturer has issued a recall on April 18, 2019 of affected Alaris
Pump Infusion Sets lots that have been identified so far and requested
facilities to remove and destroy these products.
Products affected
| Medical Device Name: Alaris Pump Infusion Set* Manufacturer: BD Switzerland Sarl Device Licence Number: 12161 | ||
|---|---|---|
| Model Code | Lot Number | Expiration Date |
| 2478-0000 | 18116061 | November 22, 2021 |
| 18116062 | November 23, 2021 | |
| 10015414 | 18115223 | November 2, 2021 |
| 10933805 | 18116304 | November 21, 2021 |
| 2420-0007 | 19023000 | February 1, 2022 |
| 19013155 | January 31, 2022 | |
| 19013154 | January 31, 2022 | |
| 18116500 | November 22, 2021 | |
| 18115135 | November 2, 2021 | |
| 18115088 | November 2, 2021 | |
| 2420-0500 | 18116640 | November 22, 2021 |
| 18116641 | November 22, 2021 | |
| 18116703 | November 22, 2021 | |
| 2426-0007 | 18116575 | November 22, 2021 |
| 18116635 | November 21, 2021 | |
| 18116647 | November 22, 2021 | |
| 18116648 | November 22, 2021 | |
| 18116657 | November 22, 2021 | |
| 18116658 | November 22, 2021 | |
| 18115006 | November 1, 2021 | |
| 18115007 | November 1, 2021 | |
| 18115132 | November 2, 2021 | |
| 2426-0500 | 18115003 | November 1, 2021 |
| 18115004 | November 2, 2021 | |
| 18115129 | November 2, 2021 | |
| 19013152 | January 31, 2022 | |
| 19013153 | January 31, 2022 | |
| 19023005 | February 1, 2022 | |
| 2477-0000 | 18115199 | November 2, 2021 |
| 18115200 | November 2, 2021 | |
| 2477-0007 | 18116521 | November 22, 2021 |
| 18116637 | November 22, 2021 | |
| 18116638 | November 22, 2021 | |
| 18116751 | November 22, 2021 | |
| 18116752 | November 23, 2021 | |
| *The Alaris Pump Infusion Set is used with the Alaris 8100 Pump Module (Device Licence Number 12364). | ||
The
manufacturer is in the process of identifying all affected Alaris Pump
Infusion Sets that have been distributed in Canada. Health Canada will
work with the manufacturer to provide an update if additional lots are
identified.
Background information
The
Alaris system is used in healthcare facilities for delivering fluids,
medications, blood, and blood products. The Pump Module is indicated for
use on adults, pediatrics and neonates.
Cases
of patients requiring medical intervention following over-infusion with
Alaris Pump Infusion Sets used with the Alaris 8100 Pump Module have
been reported. Due to a manufacturing defect in some Alaris Pump
Infusion Sets, the Alaris Pump Module mechanism is not able to fully
occlude the tubing when it is supposed to. This incomplete occlusion can
lead to unintended delivery when the pump module is not in running
status with the roller clamp open or can result in faster than expected
drug delivery flow when the pump is infusing.
Who is affected
Information for consumers
The Alaris Pump Infusion Sets and the Alaris 8100 Pump Module are used to deliver fluids, medications, blood and blood products.
The manufacturer has found that some of the Alaris Pump Infusion Sets are defective and can cause medications to be delivered when the pump is paused or delivered faster than expected. These infusion sets are only used in a hospital or surgical setting and won't impact any home IV therapy that patients maybe receiving.
The manufacturer is continuing to investigate if additional product lots are affected. Consumers should contact their healthcare providers for more information.
The manufacturer has found that some of the Alaris Pump Infusion Sets are defective and can cause medications to be delivered when the pump is paused or delivered faster than expected. These infusion sets are only used in a hospital or surgical setting and won't impact any home IV therapy that patients maybe receiving.
The manufacturer is continuing to investigate if additional product lots are affected. Consumers should contact their healthcare providers for more information.
Information for healthcare professionals
The
manufacturer has requested healthcare facilities to remove and destroy
affected lots of the Alaris Pump Infusion Sets that have been identified
so far as part of the recall.
Healthcare
professionals should continue to be vigilant when monitoring infusions
with the Alaris Pump Infusion Sets and Alaris 8100 Pump Module.
In addition, Health Canada recommends that users perform the following procedures when using these devices:
- During infusion of critical medications, check the medication bag more frequently than normal to ensure that the remaining volume corresponds to the expected delivery time. If there is less than expected medication remaining in the bag, or is the bag is empty before expected, an over-infusion event may have occurred.
- Ensure that the roller clamp on the Alaris Pump Infusion Set is closed whenever infusion is not intended.
- Follow the manufacturer’s step-by-step instructions when loading the Alaris Pump Infusion Set into the Pump Module.
- Check that no extraneous objects are caught in the pump door prior to closing it.
- Before attaching the pump to a patient, open the roller clamp and verify that no fluid is dripping through the drip chamber. If drips are observed, do not initiate infusion with the Pump Module unit and infusion set.
Action taken by Health Canada
Health
Canada is working with the manufacturer to determine the cause of
unintended delivery events and to identify all affected products that
have been distributed in Canada. Health Canada will work with the
manufacturer to issue an update if additional lots are identified or
more information becomes available.
Health
Canada is also communicating this important safety information to
Canadians via the Recalls and Safety Alerts Database on the Healthy
Canadians website (https://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php).
This communication will be further distributed through the MedEffect™
e-Notice email notification system as well as social media channels
including LinkedIn and Twitter.
Report health or safety concerns
Health
Canada’s ability to monitor the safety of marketed health products
depends on healthcare providers and consumers reporting adverse
reactions and medical device incidents. Any case of uncontrolled flow or
other serious or unexpected medical device incidents in patients
receiving infusions with Alaris Pump Infusion Sets and the Alaris 8100
Pump Module should be reported to Becton Dickinson or Health Canada.
Regulatory Operations and Enforcement Branch
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: Regulatory Operations and Regions Branch Hotline: 1-800-267-9675
The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site. (http://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html)
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
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