Advanced Perfusion System 1, Sarns Modular Perfusion System 8000, and Sarns Perfusion System 9000 의 안전성 경고

Safety alert

2013-08-26

2013-08-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130826.html

Medical device safety alert: terumo advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporation, has issued a field safety notice concerning lamp assembly of advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000. the affected catalogue numbers are 801558 (short neck lamp for terumo system 1); 801238 (long neck lamp for terumo system 1); 16420 (short neck lamp for sarns system 8000); 7278 (long neck lamp for sarns system 8000); and 144493 (positionable lamp assembly for sarns system 9000). a lamp available for use as an optional accessory with the terumo advanced perfusion system 1, sarns modular perfusion system 8000, and sarns perfusion system 9000 uses a halogen bulb which will become hot during use. there are no reported injuries as a result of this issue. however since 2007, six complaints have been received stating that plastic material or tubing have been melted, burned or deformed as a result of being placed very close to the halogen bulb or lamp housing. according to the manufacturer, heat generated from the halogen bulb in the lamp accessory can reach more than 90 degrees centigrade. this heat has the potential to melt, burn or ignite materials that may be placed in very close proximity to the bulb. heat damage to any component of the cardiopulmonary bypass circuit during a procedure would most likely require replacement of that component to complete the procedure. this could lead to an interruption of metabolic support for the patient. in addition, burn injury can occur to personnel that come in close contact with the hot lamp housing. terumo cvs is advising all users of the optional lamp accessory that it will become hot during use, and do not allow the lamp housing to touch the patient, user, perfusion circuit or other equipment during use. furthermore, terumo cvs will include the cautionary instructions in an addendum to the operator’s manual, which will be provided under separate cover. it will provide a label for the user to apply to the lamp that will contain the appropriate cautionary symbol for hot surface. this label also will be provided under separate cover. 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 26 august 2013.