smiths medical Medfusion Model 4000 syringe pump
Smiths Medical ASD Inc. · Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Pri…
Open FDA's page for this record- Cfres ID
- 205373
- Product res number
- Z-0864-2024
- Event date initiated
- 2023-12-19
- Event date posted
- 2024-02-01
- Recall status
- Open, Classified
- Res event number
- 93757
- Product code
- FRN
- Product description
- smiths medical Medfusion Model 4000 syringe pump
- Firm FEI number
- 3012307300
- Recalling firm
- Smiths Medical ASD Inc.
- Address 1
- 6000 Nathan Ln N
- City
- Minneapolis
- State
- MN
- Postal code
- 55442-1690
- Additional info contact
- icumed.custhelp.com/app/market-action 763-383-3072
- Root cause description
- Software Design Change
- Product quantity
- 60146 pumps
- Distribution pattern
- US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia
- Code info
All Medfusion Model 4000 with software versions: v1.0.0, v1.1.0, v1.1.1, v1.1.2, v1.5.0, v1.5.1, 1.6.0, v1.6.1, v1.6.4, v2.3, v2.4, v2.5, and all versions prior to v1.6.5.
- Reason for recall
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.
- Action
Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/19/2023 by letter delivered via traceable means. This notification details the issues and the affected software versions. Please note that the pump displays the installed software version on the startup screen after the pump is powered on. The notice explained the issues with the pumps, the potential risks involved with their use, and requested the following actions be taken: 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. Please ensure you have the most recent Medfusion software installed on your pumps. 2. Complete and return the attached Response Form to smithsmedical8045@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical8045@sedgwick.com. To report adverse events or product complaints: Global Complaint Management, globalcomplaints@icumed.com, 1-(866)-216-8806 Additional information or technical assistance: Technical Support, icumed.custhelp.com/app/market-action Questions about this Field Correction Notice: Field Corrections, icumed.custhelp.com/app/market-action
- K numbers
- K111386
- Harmonized identifiers (openFDA)
- Device name
- Pump, Infusion
- Medical specialty description
- General Hospital
- Regulation number
- 880.5725
- Device class
- 2
- K number
- K874546, K772094, K982170, K980751, K875348, K910425, K953731, K000842, K760370, K811918, K053554, K892210, K903788, K890736, K083689, K882249, K944733, K941595, K873776, K861001, K921050, K791720, K133532, K832641, K830017, K032147, K042405, K860353, K843772, K861539, K792050, K830605, K013767, K871807, K101194, K023083, K830490, K953098, K861598, K062699 +809 more
- Registration number
- 3024122953, 3003927385, 3010273872, 9681819, 1721686, 2523167, 3002879653, 3011270181, 3015972753, 2520313, 3005700264, 1423507, 2027804, 3047799708, 3000204189, 3012494290, 1722139, 1928237, 3004491689, 3014732157, 3017636737, 1723170, 2521402, 3005768810, 1058584, 3015158050, 3013652261, 3004167615, 2528981, 3004112621, 1123137, 3008513006, 3015192982, 3018094310, 3029973819, 2030624, 3009746061, 1061124, 2016493, 1320894 +108 more
- FEI number
- 3024122953, 3003927385, 1000114111, 3010273872, 1721686, 2523167, 3002879653, 3011270181, 3015972753, 2520313, 1000117172, 3005700264, 3002999813, 3003807466, 1000306431, 3047799708, 3000204189, 3012494290, 1928237, 3004491689, 3014732157, 3017636737, 2521402, 3005768810, 3015158050, 3001155023, 3013652261, 3004167615, 1000512168, 2528981, 3004112621, 3008513006, 3007596547, 3002807099, 3015192982, 3018094310, 3029973819, 3009746061, 1000121050, 2016493 +108 more