On 24-Aug-2020, US-FDA has released a recall alert for class I medical Device- Medfusion 3500 and 4000 Syringe Pumps due to risk of medication delivery error.

Device Use: This is used in the delivery of following products into the patient’s body in a controlled manner.

  1. Blood
  2. Blood products
  3. Prescribed medications
  4. Other fluids Syringe pumps which are primarily used in the neonatal (newly born) and paediatric populations (children group) or in operating rooms and intensive care units for the adult population.

Recall Reason:

The manufacturer of Medfusion device, ‘Smiths Medical’ recalled this product due to following reasons:

  1. Under-delivery of medication/fluids
  2. Over-delivery of medication/fluids

Manufacturer identified that the inaccurate deliveries from this device are because of software error.

The possibility of inaccurate (over- or under) deliveries can occur in the following specific sequence of events:

  1. A bolus dose is temporarily interrupted
  2. A loading dose is temporarily interrupted
  3. The pump is primed
  4. Infusion is restarted

Device Case Reports:

Smiths Medical have received four medical device incident reports (complaints) pertaining to Medfusion device issue including one serious injury. However, there were no fatal reports (death cases) received due to this issue.

Potential safety concerns:

Serious adverse health consequences including death would occur due to the use of these affected syringe pumps.

There are some potential safety concerns due to inaccurate deliveries which included overdose and serious adverse reactions (by over-delivery) which depends on certain type of medication and might cause fatal outcomes with under-delivery of important medicines which are crucial for patient life.

Class I MD 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.

Recalled Devices:

On 26-Jun-2020, Smiths Medical initiated the recall of 46,395 medical devices of below models due to this issue-

  1. Model 3500, firmware version 6.0.0
    Models 3500-0600-00, -01, -249, -51, -82
  2. Model 4000, firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0
    Models 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231

These medical devices were manufactured and distributed during the period of 01-Nov-2013 to 22-Jun-2020.

Recall Notifications from Smiths Medical:

On 26-Jun-2020, Smiths Medical sent an Urgent Medical Device Recall notice to all affected customers with the below instructions:

  • To locate all devices- “Medfusion® 3500 and 4000 Syringe Pumps” in possession and verify the firmware version to determine if the pump is impacted by this notice.
  • To ensure all personnel are aware of this medical device recall.
  • For any reason, when a bolus or loading dose delivery is interrupted, cancel the bolus or loading dose and begin a new infusion to avoid potential inappropriate delivery.
  • To complete and return the response form attached to the notice and email it to Smiths Medical at [email protected] within 10 days of receipt.
    • Distributors share the notification with customers who have received the affected product and ask each customer to complete the response form contained in the notice and return to back to the distributor.

 For Queries on this Device Recall:

Customers and Health Care professionals who have questions about this device recall can contact Smiths Medical by emailing to [email protected].

Medical Device Incidents reporting:

Health care professionals and consumers are advised to report the adverse reactions or quality issues 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
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