MedStream Programmable Infusion Pump 의 안전성 경고

Safety alert

2013-08-27

2013-08-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130827.html

Medical device safety alert: codman neuro medstream programmable infusion pump it has come to our attention that medical device manufacturer, codman neuro, depuy synthes (companies of johnson & johnson), has initiated a field safety corrective action concerning its medstream programmable infusion pump. the affected product codes are 91-4200, 91-4201, 91-4289 and 91-4290. the introduction of air into the pump reservoir during pump filling may be followed by a rapid expansion of the gas volume as air enters parts of the pump with lower pressure than the refill chamber. this will cause the drug infusion rate to exceed the programmed rate leading to drug overdose. baclofen overdose may have symptoms including muscular hypotonia, drowsiness, nausea, depressed level of consciousness, or coma; while morphine overdose may have symptoms including respiratory depression or failure, depressed consciousness, hallucinations, hypotension, nausea and vomiting, ileus and urinary retention. the manufacturer advises that following the proper fill technique will reduce the risk of air entering the system. as such, codman neuro is updating the medstream system instructions for use (ifu) and product training by adding a warning statement and additional clarifications to reinforce the proper filling technique, as detailed in the enclosed ifu table in their field safety notice sent to the affected users. all customers are asked to review the information and contact local codman neuro sales representative for additional support. furthermore, customers are advised that the following statement will be added to the medstream system ifu and to review the ifu table enclosed in the field safety notice: “air in the pump reservoir may cause the infusion rate to exceed the programmed rate leading to drug overdose. care should be taken to remove all air from the drug syringes and filling assembly prior to filling the pump reservoir. ensure that all filling components are primed with fluid and visually verify that there are no air bubbles in the filling assembly prior to filling the pump reservoir.” if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 27 august 2013.