On 05-Aug-2020, US-FDA has released a recall alert for class I medical Device- BodyGuard Infusion Pump System due to the risk of over-fusion and under-infusion.
Class I Medical Device Recall:
As per the classification system by US-FDA, this device falls under the category of Class I medical device. This is the most serious type of recall because use of these devices might cause serious injuries or death.
Intended Device Use:
This device is used in hospitals and home care settings for delivering medications and fluids into the patient’s body in the controlled amounts. It provides fluids through an infusion tubing set into a patient’s vein or through other cleared routes of administration.
Recall Reason:
The manufacturer of this medical device- ‘CME America’ has recalled this product due to the below two infusion errors:
- Over-fusion: Speed delivery (faster) than the expected delivery time of medication.
- Under-fusion: Slower delivery of medication than the expected delivery.
The manufacturer has not reported any reasons for the occurrence of these two infusion errors.
Device Case Reports:
The manufacturer has received 165 medical device incidents (complaints pertaining to this medical device infusion issues). However, there are no injuries or fatal cases reported with the use of this medical device.
Potential safety concerns:
There are some potential safety concerns due to infusion errors which included overdose and serious adverse reactions (by over-fusion) which depends on certain type of medication and might cause fatal outcomes with under-fusion of important lifesaving medicines.
Recalled Devices:
On 16-Jun-2020, CME initiated the recall of 4,877,792 medical devices of all the lots which were manufactured from 06-Mar-2009 to 26-Nov-2019 and distributed during the period of 06-May-2016 to 11-May-2020. The below models of the device were affected with recall.
Recall Notifications from CME:
On 27-Apr-2020, CME notified their respective customers via the notification letter informing them that the company is removing the BodyGuard Infusion Pumps, accessories, and infusion sets from the market. Letter included the following information:
To Share this information with appropriate personnel
Identify, remove, or discard any remaining inventory of this medical device.
To complete the customer response form, even if there are no affected products in inventory.
On 16-Jun-2020, CME sent an updated letter to customers notifying them with the issues of over-infusion or under-infusion after performing additional testing on the infusion sets used with the BodyGuard Infusion Pump System. The additional testing noted some sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in the earlier recall notification. Over-infusion or under-infusion could cause harm to patient.
For Queries on this Device Recall:
Health care professionals and consumers can contact CME by phone at (877) 263-0111, Monday through Friday between 9:00 am and 5:00 pm Mountain Time.
Medical Device Incidents reporting:
Health care professionals and consumers are advised to report the adverse incidents or quality problems associated with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and voluntarily submit the report Online.
- Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.