CELLTRACKS AUTOPREP System 의 안전성 경고

Safety alert

2014-01-22

2014-01-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122b.html

Medical device safety alert: cell search celltracks autoprep system medical device manufacturer, cell search, has issued a field safety notice concerning celltracks autoprep system (product code: 9541 and 9541r). the manufacturer has received reports of an increase in error codes related to the peristaltic pump tubing when using the celltracks autoprep system. there were also reports that the wash bowls overflowed after changing the peristaltic pump tubing following the monthly maintenance procedure. the monthly maintenance kit with part number ct9554 contains packages of peristaltic pump tubing and fluid bottle filters. peristaltic pump tubing may be ordered separately using the peristaltic pump tubing kit with part number ct4274. according to the manufacturer, monthly maintenance kits dated 20 jan 2014 or later will contain acceptable tubing. the manufacturer’s investigation determined there was a difference in the rigidity in some of the peristaltic pump tubing. tubing that is more rigid does not allow for proper fluid transfer and may result in flooding or peristaltic pump tubing fluid related errors. the manufacturer advises users of the followings: call local representatives to arrange replacement of the remaining monthly maintenance kit(s) (part no. ct9554). it is acceptable to continue to use the existing inventory of peristaltic pump tubing until replacement order arrives. discard the remaining inventory of monthly maintenance kit(s) and peristaltic pump tubing upon receipt of replacement order. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 january 2014.