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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00053-1
Product Name/Description	Curlin 6000 and Painsmart IOD Ambulatory Infusion Pumps Curlin 6000 Ambulatory Infusion Pump Product Code: 360-1400-P Multiple Serial Numbers affected Painsmart IOD Infusion Pump Product Code: 360-1300-PE5 Multiple Serial Numbers affected ARTG Number: 225964
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/01/2016
Responsible Entity	Fresenius Kabi Australia Pty Ltd
Reason/Issue	The master pumps used to calibrate the pumps that were manufactured or serviced from the 18th of March 2015 to the 6th of November 2015 were out of tolerance. Use of affected pumps may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed. Likewise the volume to be infused (VTBI) may be depleted earlier than expected resulting in delivery of overfill contained in the IV bag, if overfill is present. If overfill is not present, the pump may present an air in line or upstream occlusion alarm once the IV bag has emptied. As expected, the pump will stop infusing when either of these alarms occurs. While the potential inaccuracy of the affected pumps may be only a small fraction over the stated accuracy of the system, certain populations of patients may be affected more than others. Over delivery, or delivering at a rate of 1.2 - 6.8% faster than intended, may cause adverse serious injuries in certain patient populations.
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are advised that Fresenius Kabi Australia have undertaken a “Pre-Delivery Inspection” which included volumetric accuracy test and all the pumps in affected facilities have passed the accuracy test at the time of delivery. Fresenius Kabi representative will contact customers to arrange a time to re-calibrate the affected pumps. In the interim, users are advised to quarantine the affected pumps provided they have access to enough alternative pumps. If this is not the case, users may continue to use the affected infusion pump if a patient is deemed not to be at risk from faster than intended delivery of a medication/fluid (up to 6.8% faster). However for high-risk patients, such as those receiving inotropes or opioids and patients with renal failure, congestive heart failure or paediatric patients, an alternative pump should be sourced. This action has been closed-out on 03/03/2017.
Contact Information	02 9391 5535 - Fresenius Kabi Australia