Medfusion Model 3500 and 4000 Syringe Infusion Pumps and… recallZ-0653-2022 · Smiths Medical ASD Inc. · initiated Dec 3, 2015

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.

FDA root cause category: Component change control

What the company is doing

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.

Recall details

Recall number

Z-0653-2022

Recall class

Class II

Status

Open, Classified

Initiated by the company

Dec 3, 2015

Posted by the FDA

Feb 17, 2022

Recalling firm

Smiths Medical ASD Inc.

Quantity

38,797 (31,065 pumps and 7,732 boards)

Product code

FRN

FDA submissions

K040899, K111386

Distribution

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

Product description

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.

Other devices under the same FDA submission

15 devices cleared under K040899, K111386 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Medfusion 4000-0106-01

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls4,390 reports
• Medfusion 4000-0105-51

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls2,882 reports
• Medfusion 3500-0600-01

  Icu Medical, Inc. · Pump, infusion
  2 recalls2,041 reports
• Medfusion 3500-500

  Icu Medical, Inc. · Pump, infusion
  2 recalls2 deaths1,884 reports
• Medfusion 4000-0101-51

  Icu Medical, Inc. · Pump, infusion
  2 recalls1 death1,795 reports
• Medfusion 3500-0600-82

  Icu Medical, Inc. · Pump, infusion
  2 recalls89 reports
• MEDFUSION 4000-0106-00

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls10 reports
• Medfusion 3500-0600-00

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls9 reports
• MEDFUSION 4000-0106-231

  Icu Medical, Inc. · Pump, infusion
  2 recalls5 reports
• Medfusion 3500-0600-51

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls2 reports
• Medfusion 4000-0105-249

  Icu Medical, Inc. · Pump, infusion
  2 recalls1 report
• Medfusion 4000-0105-78

  Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION
  2 recalls0 reports