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Terminated

Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the 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.

FDA Recall Z-2554-2019 · Posted None

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeLKK
Date Initiated2018-10-15
Date Terminated2022-10-11
Product Quantity20,884 devices

Reason for Recall

Customers who utilize PharmGuard Server Software (PGS) with Medfusion 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion 4000 pumps.

Firm Action

Smiths Medical notified customers on about 10/15/2018 via "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE". Specifically, Biomed individuals (owners) at each facility were notified because they are in contact with Smiths Medical service and repair team to conduct the correction. Instructions included the following actions: 1. To determine if your facility has any devices with a duplicate wireless MAC Address, a software script must be run on the PGS Database to collect MAC Address and serial number information. The PGS Database must be at version 2.0, 2.1, or 2.2 for this data collection process to be completed. Refer to instructions on Attachment 1, Field Safety Notice Response Form, for available options to complete this data collection process, and if needed, to upgrade your PGS database and Medfusion 4000 device software/firmware. Please return the Response Form within 10 days of receipt of the Field Safety Notice. 2. If it is determined that any of your Medfusion 4000 pumps are affected by this issue, Smiths Medical Service and Repair will contact you to discuss repair options for the affected devices, based on the contact information provided on the Response Form. Questions regarding the notification can be sent to Smiths Medical via email at [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide distribution - Nationwide in the states of AL, AR, AZ, CA, CN, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV and country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc. · 2011-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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