CADD Administration Sets with Flow Stop 의 안전성 경고

Safety alert

2016-05-10

2016-05-10

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20160510a.html

Medical device safety alert: smiths medical cadd administration sets with flow stop medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its cadd administration sets with flow stop. the following products re-order numbers for devices with a device expiration date on or before march 2021 are affected: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24]. the affected products have the potential to impact flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under delivery of medication. the manufacturer’s test data indicates that under infusion has the potential to contribute to an average of an additional 5.2% under delivery beyond the +/- 6% stated in the operator’s manual for the cadd pumps. the manufacturer’s risk analysis identified the following possible serious adverse health consequences with a very remote probability of occurrence: 1) inadequate symptom control (dependent on therapy being delivered). for example: increase in pain or increase in cardiac symptoms (heart rate, rhythm, blood pressure); 2) inadequate treatment (dependent on therapy being delivered). for example: subtherapeutic doses delivered of medication in which a specific volume needs to be infused such as antibiotics, chemotherapy, or nutritional therapy. the manufacturer concluded that there is a very remote probability that under delivery may occur resulting in patient harm, as all possible levels of patient harm were evaluated to be rare. the manufacturer is not requesting return of product. the manufacture advises users to continue to monitor for under delivery when utilising the cadd administration sets with flow stop. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 may 2016.