Events

Safety Alert for Gemstar Infusion 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
    2013-03-25
  • Event Date Posted
    2013-03-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130325.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 gemstar infusion pump medical device manufacturer, hospira inc has initiated a field safety corrective action concerning gemstar infusion pump which four potential risks were identified to be related to the device. the affected list numbers are 13000, 13150 and 13087. according to hospira, the affected pumps may have the following problems: (1) gemstar lithium battery - low voltage 11/004 error will be displayed and the device will not be able to be used (2) gemstar battery leakage aa battery leakage may cause the device to shut off without warning (3) gemstar pressure sensor calibration drift the proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test. (4) gemstar backward motor movement when the pump is stopped or the flow rate is less than 2.0 ml/hour, the motor assembly may rotate backwards capturing additional medication that will be delivered. x091/001 error will be displayed. hospira warns the users that a delay in therapy may be resulted. the affected users are advised to: replace lithium batteries that are older than three years; inspect the internal aa batteries and battery compartment for signs of leakage, corrosion or other damage prior to each use; add the proximal and distal occlusion test to the yearly gemstar maintenance schedule and remove the device from clinical use if it fails either of the tests; remove the device from clinical use if it displays an x09/001 error. the local supplier confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 march 2013.

Device

Gemstar Infusion Pump
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Gemstar Infusion Pump
  • Manufacturer
    Hospira Inc

Manufacturer

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