Events

Safety Alert for I-Flow On-Q Pump C-Cloc with Ondemand Bolus button

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by I-Flow Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-06-15
  • Event Date Posted
    2012-06-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120615a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: i-flow on-q pump c-cloc with ondemand bolus button the health canada posted a medical device safety alert concerning on-q pump c-cloc with ondemand bolus button (model number cb003 and cb006), manufactured by i-flow corporation. the manufacturer recently determined that in a small quantity of on-q pumps including the ondemand bolus button, the valve that activates flow of local anesthetic from bolus reservoir to the patient is defective. in this condition, patients may receive continuous infusion of local anesthetic to the tissue space at a rate greater than desired (i.E. main basal rate + bolus reservoir fill rate). for details, please refer to health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php. if you are in possession of the product, please contact your supplier for necessary actions. posted on 15 june 2012.

Device

I-Flow On-Q Pump C-Cloc with Ondemand Bolus button

Manufacturer

I-Flow Corporation