Animas 2020 Insulin Infusion Pump 의 안전성 경고

Safety alert

2013-02-05

2013-02-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130205.html

Medical device safety alert: animas 2020 insulin infusion pump health canada has posted a medical device safety alert concerning animas 2020 insulin infusion pump manufactured by animas corporation. the affected model/catalogue numbers are 100-380-51, 100-381-51, 100-382-51, 100-384-51, 100-385-51 respectively. a small number of animas 2020 insulin infusion pumps are potentially affected by a misalignment of a component on the printed circuit board assembly. this component misalignment results in the insulin pump potentially measuring force conditions incorrectly, resulting in false warnings and/or alarms. should the patient complete a load sequence or prime the insulin infusion pump and does not disconnect from the infusion set from the body, the insulin infusion pump may dispense all of the insulin in the cartridge into the patient. there is no safety risk as long as the patient follows the instructions for use and always disconnects the infusion set prior to priming the pump, changing the cartridge, and rewinding the motor. according to the local supplier, the affected products are not distributed in hong kong. for details, please visit the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/ rec-ret_md-im_date_jan-mar_2013-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted on 05 february 2013.