SynchroMed Implantable Infusion Pump 의 안전성 경고

Safety alert

2012-11-20

2012-11-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121120a.html

Medical device safety alert: medtronic synchromed implantable infusion pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed implantable infusion pump, manufactured by medtronic limited. from the manufacturer’s investigation, use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. based on data from medtronic’s implantable systems performance registry, the overall failure rate of the synchromed ii pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs. the use of unapproved drugs can lead to intermittent or permanent pump motor stalls which may be reported as a loss of or change in therapy. therapy changes could potentially result in serious injury and/or death. pumps can experience motor stalls when used with either approved or unapproved drugs, however pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used. medtronic continues to investigate motor gear corrosion, which has been identified as a primary contributor to permanent motor stall in both synchromed ii and synchromed el pumps. to minimize the potential for motor stall, the manufacturer advised user to only use the approved drugs that are identified in the synchromed infusion system labelling. do not use compounded drugs, unapproved concentrations or unapproved formulations. the manufacturer also provided the following recommendations: continue to monitor patients closely for the possible return of baseline symptoms. reinforce with patients and caregivers information on the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare provider immediately if these signs and symptoms appear. the synchromed ii pump is designed with a critical alarm for pump motor stall. for patients implanted with a synchromed ii pump, the critical alarm interval frequency can be changed to sound every 10 minutes. retrieve logs when interrogating the synchromed ii pump in order to check for motor stall events. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to mhra website http://www.Mhra.Gov.Uk/home/groups/fsn/documents/ fieldsafetynotice/con205372.Pdf if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 november 2012.