Events

Safety Alert for Infusion Pumps

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

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
    2013-03-22
  • Event Date Posted
    2013-03-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130322.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hospira infusion pumps it comes to our attention that the notified body national standards authority of ireland (nsai) has suspended the quality management systems certificates (iso 13485) for hospira’s manufacturing facilities in lake forest and costa rica with effect from 28 february 2013. the health canada and the medicines and healthcare products regulatory agency (mhra), united kingdom had posted safety alerts on their website to inform the public of the issue and the current actions taken by the manufacturer. details could be found at the following websites: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/25869a-eng.Php http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/26209a-eng.Php http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con244550 according to hospira, all new infusion pumps are being held globally under quarantine status, and no new pumps are to be placed on the market until the certificate suspension is lifted. however, the infusion pumps in fields are still to be serviced, maintained and repaired. healthcare professionals are advised to weight the risk/ benefit to patients associated with the use of the device when administering critical therapies. customers are advised to consider the use of an alternative pump, particularly in patients in which a delay/ interruption of therapy could result in serious injury and death. in hong kong, the following hospira infusion pumps are listed under the medical device administrative control system (mdacs): infusion pump, plum a+ (hkmd no.: 100165) plum a+3 infusion pumps (hkmd no.: 100395) plum xld (hkmd no.: 110133) gemstar infusion pump (hkmd no.: 110474) in view of the failure in complying with the mdacs requirements, the above products were temporarily delisted with immediate effect. the status of this temporary delisting will be reviewed 3 months later from today. posted on 22 march 2013.

Device

Infusion Pumps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Infusion Pumps
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DH