Medfusion 4000 Syringe Infusion Pumps recallZ-0540-2014 · Smiths Medical ASD, Inc. · initiated Nov 22, 2013

Why it was recalled

Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po

FDA root cause category: Device Design

What the company is doing

Smiths Medical sent an "Urgent Medical Device Correction" letter dated November 22, 2013, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. All customers will be provided with instructions on inspection, cleaning, and prevention regarding this issue, for the continued safe and effective use of these pumps. Additionally, customers will be instructed to: 1. Return damaged pumps for servicing or damaged AC power cords for replacement to Smiths Medical. 2. Return the completed Confirmation Form to acknowledge receipt and understanding of the information provided in the Urgent Medical Device Correction letter, via fax or email, to Smiths Medical for processing. "The Instructions for preventing this issue", "Mitigations", Conclusions", " Action to be taken by the User", and "Transmission of this Urgent Medical Device Correction". The consignees were also asked to complete the "Urgent Medical Device confirmation Form" and fax it to 1-800-237-8033 or by sending an electronic copy via e-mail to [email protected]. For questions regarding this information, consignees should contact their local Sales Representative, Smiths Medical's Customer Service Department at 1-800-258-5361, or via e-mail at [email protected]. UPDATE: Consignees were sent a follow-up letter dated 13 January 2014 from the one dated November 22, 2013. The letter was addressed to Risk / Safety Managers, Biomedical Professionals, Clinicians who oversee the use of Medfusion Pumps, Distributors, and other users of these devices. The "Urgent Medical Device Recall" letter included Advise on Action to be Taken by the User. This included customers to have their Pumps undergo a free correction. The correction consists of the installation of a new AC power Receptacle seal. Smith Medical provided options for completing the correction process which included: 1) Consignees were a

Recall details

Recall number

Z-0540-2014

Recall class

Class II

Status

Terminated

Initiated by the company

Nov 22, 2013

Posted by the FDA

Dec 19, 2013

Recalling firm

Smiths Medical ASD, Inc.

Quantity

9560 (8601 US, 959 OUS)

Product code

FRN

FDA submissions

K111386

Distribution

Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.

Product description

Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.

Other devices under the same FDA submission

14 devices cleared under 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 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
• MEDFUSION 4000-0107-01

  Icu Medical, Inc. · Pump, infusion
  1 recall3 reports