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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00065-1
Product Name/Description SynchroMed II Infusion System and Model 8870 Software Application Card used in the 8840 N’Vision Clinician Programmer

SynchroMed II Infusion System
ARTG Number: 97770

8840 N’Vision Clinician Programmer
ARTG Number: 104700
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 25/01/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue This action is a follow up to the July 2013 communication regarding the SynchroMed II priming bolus function and to inform that Medtronic is updating the Model 8870 software application card as well as the SynchroMed Infusion System labelling to address the issue.

The software update will change the value displayed on the 8840 programmer for the SynchroMed II pump tubing volume from 0.199 mL to 0.140 mL. Over delivery of drug during priming bolus has the potential to lead to overdose symptoms in some patients. This software change mitigates the potential for unintended over-delivery of drug while still ensuring prompt therapy initiation.

The SynchroMed II Infusion System Manuals were updated for the priming bolus function, and new guidelines for priming have been implemented.
Recall Action Recall for Product Correction
Recall Action Instructions Doctors are advised to continue to use the current software card and its displayed tubing volume until the Medtronic Representative has exchanged the current card with the new software card (new version is BBU01). New guidelines in labelling regarding priming bolus are identified in the customer letter and the attachment provided with the letter.

This action was closed out on the 25/09/2018.
Contact Information 1800 652 972 - Medtronic Neuromodulation Patient Services