Gemstar Infusion Pump 의 안전성 경고

Safety alert

2013-03-25

2013-03-25

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130325.html

Medical device safety alert: hospira gemstar infusion pump medical device manufacturer, hospira inc has initiated a field safety corrective action concerning gemstar infusion pump which four potential risks were identified to be related to the device. the affected list numbers are 13000, 13150 and 13087. according to hospira, the affected pumps may have the following problems: (1) gemstar lithium battery - low voltage 11/004 error will be displayed and the device will not be able to be used (2) gemstar battery leakage aa battery leakage may cause the device to shut off without warning (3) gemstar pressure sensor calibration drift the proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test. (4) gemstar backward motor movement when the pump is stopped or the flow rate is less than 2.0 ml/hour, the motor assembly may rotate backwards capturing additional medication that will be delivered. x091/001 error will be displayed. hospira warns the users that a delay in therapy may be resulted. the affected users are advised to: replace lithium batteries that are older than three years; inspect the internal aa batteries and battery compartment for signs of leakage, corrosion or other damage prior to each use; add the proximal and distal occlusion test to the yearly gemstar maintenance schedule and remove the device from clinical use if it fails either of the tests; remove the device from clinical use if it displays an x09/001 error. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 march 2013.