Date Initiated by Firm | June 29, 2012 |
Date Posted | August 15, 2012 |
Recall Status1 |
Terminated 3 on August 26, 2015 |
Recall Number | Z-2185-2012 |
Recall Event ID |
55121 |
510(K)Number | K950419 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Alaris Pump Module model 8100.
Subsequent product code: FPA
The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates. |
Code Information |
All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0 |
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
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For Additional Information Contact | 858-617-4000 |
Manufacturer Reason for Recall | The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questions were instructed to contact customer advocacy at (800) 854-7128, option 1, option 1, option 3 or email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system were instructed to contact Technical support at (888) 812-3229.
For questions regarding this recall call 858-617-4000. |
Quantity in Commerce | 102,248 units |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada.
Additional Countries: Netherlands. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = FRN
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