smiths medical Medfusion Model 3500 Syringe pump
Smiths Medical ASD Inc. · Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infus…
Open FDA's page for this record- Cfres ID
- 205366
- Product res number
- Z-0863-2024
- Event date initiated
- 2023-12-19
- Event date posted
- 2024-02-01
- Recall status
- Open, Classified
- Res event number
- 93754
- Product code
- FRN
- Product description
- smiths medical Medfusion Model 3500 Syringe pump
- Code info
- All Medfusion Model 3500 pumps with software v3.X, v4.X, and v5.0.0 and was addressed in software v6.0.0 (2012) and all subsequent versions.
- 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
- Field Corrections 763-383-3072
- Root cause description
- Software Design Change
- Product quantity
- 93177 pumps
- Distribution pattern
- worldwide
- Reason for recall
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. 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 (v6.0.0) installed on your pumps.
- Action
Smiths Medical issued an URGENT MEDICAL DEVICE CORRRECTION notice to its consignees on 12/16/2023 by letter delivered via traceable means. 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. Inquires: 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
- K040899
- 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