—#190636

Product

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K040899, K111386
Affected lot / code info: Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced.

Why it was recalled

There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.

Root cause (FDA determination)

Component change control

Action the firm took

The firm issued Customer Information Bulletin dated 03-Dec-2015. It explained the details of the issue and provides the consignee a list of serial numbers for pumps in their facility that may be impacted. In addition, it informs the consignee if they have purchased main boards between April 2012 and June 2015 for part numbers G6000361, G6000435, G6001260, G6001560 and G6002728, they are included in the enclosed file. The consignee is to contact the recalling firm to make arrangements to begin the replacement process. If the Supercap Post alarm or the Backup Audible Alarm error code occurs prior to replacement, the consignee is to immediately remove the pump from service for repair by a trained biomedical technical at the recalling firm or at their facility. If the device with the affected serial number is sent to the recalling firm for any other unrelated repair, the supercapacitor will be replaced at that time. No response form was enclosed with the bulletin.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.

Timeline

Recall initiated: 2015-12-03
Posted by FDA: 2022-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190636. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.