Events

Safety Alert for (1) CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
  • Event ID
    102
  • Date
    2001-07-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The fda issued on july 20, 2001, a public health alert that warns health establishments of the potential for patient aggravations when cytogenetic gas cylinders are mistakenly connected to o2 supply systems, patients receive other gas, such as nitrogen, other than medical o2. fda received report on 7 orbits and 15 aggregates, over the last 4 years, related to the erroneal connection of hospital gas in intensive therapy units and domiciliary attention units.
  • Action
    ACTION REQUIRED: The FDA RECOMMENDS THAT ALL OPPORTUNITIES TO PROMOTE THE PROPER HANDLING OF HOSPITAL GASES, AS WELL, OF RELATED CYLINDERS AND CONNECTORS, ARE ACCEPTED. TO THE FOLLOWING: (1) WHEN CONNECTING A CYLINDER, CAREFULLY EXAMINE THE LABEL TO ENSURE THAT THE GAS CONTAINS THE GAS ADEQUATE TO ITS APPLICATION, TO AVOID POSSIBLE AGGREGATES ARISING FROM ERRONE CONNECTION OF HOSPITAL GAS CYLINDERS. (2) NEVER USE ADAPTERS OR CHANGE CONNECTORS OR PLUG IN A CYLINDER. IF A CONNECTOR DOES NOT JOIN THE O2 SUPPLY SYSTEM, PROBABLY THE GAS IN WHICH CYLINDER IS NOT O2 AND, THEREFORE, SHOULD NOT BE USED. (3) MAKE SURE THAT ALL PERSONNEL HANDLING HOSPITAL GASES ARE PROPERLY TRAINED AND UNDERSTAND THE OPERATIONS AND CONNECTIONS OF HOSPITAL GAS SYSTEMS AND LABELS. (4) IF YOUR ESTABLISHMENT RECEIVES BOTH HOSPITAL AND INDUSTRIAL GASES, STORE IN SEPARATE LOCATIONS. TO REPORT ADVERSE EVENTS RELATED TO HOSPITAL GASES, CONTACT THE MANUFACTURER OF THE CYLINDER, OR SEND CORRESPONDENCE TO ANVISA, ON THE INTERNET WWW.ANVISA.GOV.BR/TECNOVIGILÂNCIA/ FORMS OR BY THE E-MAIL TECNOVIGILANCIA@ANVISA.GOV.BR.

Device

(1) CRYOGENIC HOSPITAL GAS CYLINDERS; (2) OXYGEN SUPPLY SYSTEMS (3) HOSPITAL GAS VALVE CONNECTORS)
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA