MedStream Programmable Infusion System 의 안전성 경고

Safety alert

2013-06-20

2013-06-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130620.html

Medical device safety alert: depuy synthes medstream programmable infusion system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning medstream programmable infusion system manufactured by codman neuro, depuy synthes. all serial numbers distributed with product codes 91‐4200 (20 ml pump) and 91‐4201 (40 ml pump) are potentially affected. the safety alert is related to a miscalibrated fill level sensor (fls). fls is a feature of the medstream pump that measures the drug volume remaining in the pump reservoir and reports this value via the medstream control unit (programmer). the drug volume measurement is used to calculate a recommended refill date based on the average daily flow rate of the pump. the manufacturer found that in some instances, the fls calibration may have been altered during the sterilization process. a miscalibrated fls may under or over report the drug volume remaining in the pump. this error may have the following impact on the pump's function: the pump's low reservoir alarm, normally set to sound at 3ml, may sound too late the recommended pump refill date computed by the control unit will be incorrect the clinical manifestation of a pump with a miscalibrated fls may include: a clinically significant drug underdose may occur if the pump reservoir runs empty; or a return of underlying symptoms and/or withdrawal symptoms may occur if the volume in the pump is incorrectly reported and the physician responds by altering dosage levels. the manufacturer explained that based upon reported complaints, approximately 1% of implanted medstream pumps may have been affected by this issue. there have not been any reports of corresponding deaths or permanent patient injuries. the manufacturer advises users to: l follow the recommendations in the document "worksheet to identify pumps with a miscalibrated fls" enclosed in the field safety notice, during each patient's next scheduled refill session, or sooner if the patient is symptomatic. notify the manufacturer if the pump is identified to be miscalibrated; and follow the recommendations as mentioned in the field safety notice to manage patients who are identified as having a miscalibrated fls. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286830 posted on 20 june 2013.