Alerte De Sécurité sur Primary Plumset

Safety alert

2013-05-22

2013-05-22

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130522.html

Medical device safety alert: hospira primary plumset it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning its primary plumset. the affected list numbers are as follows: 12193 - plum a+ infusion set with 2 clave needle free ports above pump. polyethylene lined light protected set. flotation ball in drip chamber 12194 - plum a+ infusion set with 2 clave needle free ports above pump. flotation ball in drip chamber 12195 - plum a+ infusion set with 4 clave needle free ports above pump. polyethylene lined light protected set. flotation ball in drip chamber 12196 - plum a+ infusion set with 2 clave needle free ports above pump. transparent polyethylene lined set. flotation ball in drip chamber the manufacturer has received customer complaints involving the plum a+ infusion set with clave needle free ports. the plum a+ infusion set with clave needle free ports above the pump can be used for treatments that include the sequential administration of up to 4 medications plus a primary diluents (such as saline of glucose) in appropriately assessed patients. as result of sequential administration of up to 4 medications, there can be the potential for contamination of the primary diluent (saline) between the administrations of more than one drug. if the fluid level is not maintained in the sight chamber during infusion it is possible that manipulations to refloat the ball in the chamber may result in a small amount of retrograde flow of drug from the secondary (medication) line into the primary (diluent) line. there is the potential for the primary diluent to become contaminated by cytostatic drugs in a multi-therapy oncology administration. contamination of primary diluent(s) with cytostatic drugs may cause under delivery if administration of primary medication is not completed per clinical practice, or particulate matter resulting from mixing of incompatible medications. the manufacturer advises users to follow instructions mentioned in the field safety notice, when priming and flushing with more than one secondary medication, and when delivery of sequential medications per healthcare provider policy. furthermore, hospira is updating the patient information leaflet and training literature, and will be providing a training implementation plan to all applicable healthcare professionals. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 may 2013.