Alerta De Seguridad para Receptal System Liners and Canisters

Safety alert

2013-09-17

2013-09-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130917a.html

Medical device safety alert: hospira receptal system liners and canisters the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning receptal system liners and canisters manufactured by hospira inc. hospira has become aware that customers may be inappropriately using incorrectly sized receptal liners with receptal canisters (e.G. 1.5l liner, 2l liner or 3l liner with a 1l canister). to date, hospira has received reports associated with this practice, including one case resulted in serious injury and one case resulted in death. hospira explains that the lid may not fit and the suction will not be sufficient and/or consistent if incorrectly sized liners are used. if suction is compromised during a general surgical procedure, the fluids may impair the surgeon’s vision and ability to expeditiously complete the procedure. the harm includes progression of the untreated condition that may result in symptoms such as hypertension, tachycardia, and bradycardia. furthermore, the delay may result in a prolonged exposure to any anaesthesia used during the procedure. compromised suction leads to diminished efficacy of the product and/or delay in therapy, both of which can result in life threatening situations if airway clearance or gastric suction is needed. therefore, hospira recommends that hospira/abbott canisters should only be used with appropriately sized hospira/abbott receptal lid/ liners. hospira recommends the users to follow the receptal set up instructions which reminds the users to fully extend and insert the liner. in addition, hospira will update the instructions for use to reflect the appropriate use of the affected products. for instance, a 1l liner should be matched with a 1l canister and hospira/abbott liners should be matched with hospira/abbott canister. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con314890 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2013.