Bodyguard pumps (2021-09-16)

Starting date:

September 16, 2021

Posting date:

October 8, 2021

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-76601

Last updated:
2021-10-08

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  Reason
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  Affected products

Affected Products

A. Bodyguard Twins - Pump

B. Bodyguard 323 IV Infusion Pump | Bodyguard 323 -510 refurbished Pump kit

Reason

Based on customer feedback, CME has identified potential flow rate issues when using the CME bodyguard microsets/bodysets infusion sets, with the associated CME bodyguard infusion pump. The investigation showed an increased risk of under-infusion when using the pump system at high flow rate settings in both continuous and an intermittent infusion like PCA mode. Deviations of nominal accuracy (5-7%) were detected above 500 Ml/Hr and were most prevalent and significant (20%) When running infusions at flow rates 800 Ml/hr in continuous mode. Similarly, when PCA Bolus (intermittent) are delivered at rates 500 Ml/hr in combination with low basal rates. The investigation showed an increased risk of under-infusion when using the pump system at high flow rate settings in both continuous and an intermittent infusion like pca mode. Deviations of nominal accuracy (5-7%) were detected above 500 ml/Hr and were most prevalent and significant (20%) When running infusions at flow rates 800 Ml/Hr in continuous mode. Similarly, when PCA Bolus (intermittent) are delivered at rates  500 Ml/Hr in combination with low basal rates.

Affected products