Spectra Optia Apheresis System 의 안전성 경고

Safety alert

2013-08-23

2013-08-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130823.html

Medical device safety alert: terumo bct spectra optia apheresis system medical device manufacturer, terumo bct, inc., has issued a field safety notice concerning spectra optia apheresis system. terumo bct has modified the spectra optia system’s standard filler in order to reduce the incidence of leaks in the channel of the tubing set during mononuclear cell (mnc) collection procedures. leaks in the channel of the tubing set have many different causes. the manufacturer has identified a very specific type of channel leak caused by a pinhole-sized tear in the soft vinyl wall near the set’s hard plastic connector. this type of leak has occurred primarily during long mnc collection procedures and results in a minor blood spill that remains fully contained within the system’s centrifuge chamber. although the reported incidence of this type of channel leak is quite low (< 0.23% in spectra optia collection sets manufactured since july, 2010) and no serious adverse events have been reported, even a small tubing set leak can result in the premature termination of an apheresis procedure. consequently, terumo bct has modified and strengthened the system’s standard filler to better support the tubing set during centrifugation. according to the manufacturer, to help identify the modified filler, “spectra optia” is engraved on the top side of the filler. terumo bct will provide one modified standard filler for each device to all customers who use the system to perform mnc collection procedures. the manufacturer will begin installing the modified filler over a 12-month period, with the installation likely occurring during a scheduled preventive maintenance visit. the machine’s original filler will be removed from facility for recycling/disposal. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 august 2013.