Events

Safety Alert for Venisystems Blood Bottle Pumpset with CAIR Clamp

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
    2013-11-18
  • Event Date Posted
    2013-11-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131118a.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 venisystems blood bottle pumpset with cair clamp it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning venisystems blood bottle pumpset with cair clamp. the details of the affected devices are as follows: list number: a) 04643-97-01; b) 12697-65; c) 12720-65 lot number: a) 040945g, 131335g; b) 281145h, 180015h, 040115h, 880485h, 782245h, 680585h; c) 161475h, 153405h, 032595h there are increased complaints of backflow of fluid, incorrect assembly and no flow associated with the affected intravenous administration sets, which have resulted in retrograde flow. incorrect assembly of the bulb pump has the potential to prevent delivery of blood to the patient resulting in a delay of therapy. it may result in death or serious injury if a prolonged delay in the administration of life-sustaining blood products occurs. no reports of injury to patients have been received to date. the manufacturer advises users not to use and immediately quarantine the affected products, and return them to the manufacturer. hospira is improving the manufacturing process to address incorrect assembly. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2013.

Device

Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Manufacturer
    Hospira

Manufacturer

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