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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion Syringe Infusion Pump, Models 3500 & 4000

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  Class 2 Device Recall Medfusion Syringe Infusion Pump, Models 3500 & 4000 see related information
Date Initiated by Firm December 03, 2015
Date Posted February 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-0653-2022
Recall Event ID 89144
510(K)Number K111386  K040899  
Product Classification Pump, infusion - Product Code FRN
Product Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
Code Information Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Mr. Eric Peterson
763-383-3469
Manufacturer Reason
for Recall		 There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
FDA Determined
Cause 2		 Component change control
Action The firm issued Customer Information Bulletin dated 03-Dec-2015. It explained the details of the issue and provides the consignee a list of serial numbers for pumps in their facility that may be impacted. In addition, it informs the consignee if they have purchased main boards between April 2012 and June 2015 for part numbers G6000361, G6000435, G6001260, G6001560 and G6002728, they are included in the enclosed file. The consignee is to contact the recalling firm to make arrangements to begin the replacement process. If the Supercap Post alarm or the Backup Audible Alarm error code occurs prior to replacement, the consignee is to immediately remove the pump from service for repair by a trained biomedical technical at the recalling firm or at their facility. If the device with the affected serial number is sent to the recalling firm for any other unrelated repair, the supercapacitor will be replaced at that time. No response form was enclosed with the bulletin.
Quantity in Commerce 38,797 (31,065 pumps and 7,732 boards)
Distribution Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.
510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.
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