ClearanceBrief
Recall Z-2554-2019 ยท LKK Pump, Infusion, Implanted, Programmable

Smiths Medical ASD Inc.

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

DateOct 15, 2018
StatusTerminated
ReasonCustomers 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.
Root causeProcess control
ActionSmiths 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 proc
Quantity20,884 devices
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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