Events

Safety Alert for GemStar™ Bolus Cord used with Gemstar™ Pump

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

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
    2012-03-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322d.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
    Field safety notice: hospira gemstar™ bolus cord used with gemstar™ pump it has come to our attention that the health canada was aware of problems associated with the gemstar™ bolus cord, used with the gemstar™ pump manufactured by hospira inc. post-market incident reports indicate that defects with these cords can lead to failure to deliver, intermittent operation, and unrequested bolus delivery. the gemstar™ pump has software controls that set a maximum allowable dosage and minimum lockout time. an audible chirp signals for every requested delivery and provides notification to the patient and attendant staff. these safety provisions help to mitigate the potential risk to the patient. the health canada has not received any reports of patient injury. the manufacturer's preliminary investigation suggests that the cord may be damaged by the force applied to remove the cord from the base of the gemstar™ unit. this may lead to cracking and open circuits or short circuits. if you are in possession of the product, please contact your supplier for necessary actions.

Device

GemStar™ Bolus Cord used with Gemstar™ Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira GemStar™ Bolus Cord used with Gemstar™ Pump
  • Manufacturer
    Hospira Inc

Manufacturer

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