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U.S. Department of Health and Human Services

Class 2 Device Recall CADD Solis VIP

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  Class 2 Device Recall CADD Solis VIP see related information
Date Initiated by Firm October 31, 2016
Create Date March 10, 2017
Recall Status1 Terminated 3 on July 15, 2019
Recall Number Z-1439-2017
Recall Event ID 76189
Product Classification Pump, infusion, pca - Product Code MEA
Product CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
Code Information 1071155, 1076826, 1081258, 1081260, 1081275, 1082475, 1082511, 1082512, 1090347, 1090348, 1090349, 1091767, 1091768, 1091769, 1091770, 1091771, 1092395, 1100186, 1100188, 1100189.
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact Smiths Medical Representative
651-633-2556
Manufacturer Reason
for Recall		 20 Pumps sold to the Finnish market contain a message in which one word in the message is mistranslated. When the user follows a specific set of key presses the pump will display the incorrect message. The message indicates that a Patient Controlled Analgesia (PCA) dose is unavailable because the pump is running. It should indicate that the PCA dose is not available because the pump is stopped. The function of the pump is unchanged and no patient injury can occur since no drug is being delivered.
FDA Determined
Cause 2		 Software design
Action Smiths Medical sent an Urgent Medical Device Field Safety Notice dated October 26, 2016, via FedEx on October 31, 2016. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to contact the Smiths Medical Service & Repair Department for the software to be loaded and to complete the Recall Confirmation Form and return it to Smith Medical via e-mail to FCA.Response@Smiths-medical.com. For further questions please call (651) 633-2556.
Quantity in Commerce 20
Distribution Internationally to Finland
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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