Events

Safety Alert for Q core’s Sapphire 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
    2016-05-24
  • Event Date Posted
    2016-05-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160524b.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 q core’s sapphire infusion pumps medical device manufacturer, hospira, has issued a medical device safety alert concerning q core’s sapphire infusion pumps (hospira list number: 163113601). the manufacturer’s investigation and analysis has determined that with specific drug concentrations of iron sucrose (range of 0.7 to 2.8mg/ml, “concentration range”) the pump may misinterpret the iron sucrose solution as air rather than an opaque solution, resulting in the generation of a false air-in-line alarm. risk to health is limited to a delay in the administration of iron sucrose infusion in the concentration range only. the issue, if occurs, is immediately apparent to the provider at the beginning of the treatment as an air-in-line alarm is generated, which does not allow the treatment to start. in addition, iron sucrose therapy is not used for acute treatment of anaemia, the effected of iron sucrose takes days to occur, and alternative delivery mechanism are readily available. thus the risks of delay in therapy of intravenous iron sucrose are remote. according to the manufacturer, intensive research has not revealed any other medication which raises the same issue, i.E., this issue is unique for iron sucrose and no other drug. the software algorithms within the pump are being improved to restore the device to its original specifications, enabling consistent delivery of the aforementioned concentration of iron sucrose. this improvement will address the root cause and prevent the false alarms. according to the local supplier, 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 24 may 2016.

Device

Q core’s Sapphire Infusion Pumps
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Q core’s Sapphire Infusion Pumps
  • Manufacturer
    Hospira

Manufacturer

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