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Medfusion Syringe Pump 3500 Series recallZ-1135-2018 · Smiths Medical ASD Inc. · initiated Nov 13, 2017

Class II Terminated All recalls posted in March 2018

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.

FDA root cause category: Process change control

What the company is doing

Consignees were notified via mail on 11/13/2017, 01/09/2018, and 02/12/2018, as a result of expansions of the recall and the need to provide additional instructions and information to consignees. Instructions in the first letter date 11/13/2017 instructed customers to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to utilize the enclosed Reference Tool when verifying syringe size, and to complete the return the Response Form. Instructions in the letter dated 01/09/2018 included to always confirm the accuracy of infusion values to the original order, including verifying syringe size, to advise all clinicians overseeing use of the affected devices to utilize the enclosed Reference Tool, to remove the pump if the syringe is not recognized or is read as an incorrect size during programming or infusion, to notify impacted customers if the devices were further distributed, and to complete the return the Response Form. Instructions in the letters dated 02/12/2018 included to identify any affected devices on hand, complete and return the Urgent Medical Device Recall Response Form, and arrange for repair of the affected as per the location of the consignee in Canada or the USA. If the consignee is located in the USA, the three options include to return to Smiths Medical for repair, arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair, or arrange for onsite repair by Smiths Medical if there are more than 10 pumps onsite. If the consignee is located in Canada, the two options include to return to Smiths Medical for repair or arrange for the shipment of the required parts and have the consignee's onsite Biomed Team complete the repair. Consignees not located in the USA or Canada were instructed to contact their Smiths Medical Representative to discuss repair options. For further questions, please send inquiries to [email protected].

Recall details

Recall number
Z-1135-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 13, 2017
Posted by the FDA
Mar 5, 2018
Recalling firm
Smiths Medical ASD Inc.
Quantity
16,600 pumps total
Product code
FRN
FDA submissions
K040899
Distribution
Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.

Product description

Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

Code information (models, lots, serial numbers)

Product Codes 3500G, 3500VX, 3500-414, 3500-402, 3500-0600-249, 3500-0600-00, 3500-0600-01, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-415, 3500-500

Other devices under the same FDA submission

1 device cleared under K040899 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 78922).

Sources and updates

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