Events

Safety Alert for All Pulse Oximeter Sensors

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
    742
  • Date
    2003-09-17
  • 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
    1. Alert the hospital staff regarding this problem; 2. Ensure that clinical protocols include a check on the integrity of all SpO2 (disposable and reusable) sensors before they are placed in a patient or when they are removed to a new location. Specifically, the sensor and cable must be inspected for cracks or breaks in insulation, exposing electrical connections or wiring, and for any other damage. (Note: disposable sensors should be reused only on the same patient as per the manufacturer's instructions for use); 3. Instruct health care professionals to follow the manufacturer's instructions, assess the skin's integrity at the sensor site and when to change the sensor locations. By doing this, it will help to make sure that any injuries that occur are dealt with immediately; 4. Alert the staff not to use a damaged sensor or sensor cable. The sensor or cable should be clearly labeled as damaged and sent to clinical engineering or maintenance staff for evaluation and to allow occurrences of such problems to be tracked.
  • Reason
    A nurse from a hospital noticed that a patient had a skin lesion on the side where the pulse oximeter sensor was placed. the nurse suspected the cause of the injury by being spo2 (single use / disposable) sensor that was subsequently removed to a different place in the patient. when the nurse removed the sensor, the skin was reddened; however, there was no evidence of an injury. a large part of the insulation that is normally present on the sensor led was missing (it was shattered or broken). as a result, one of the electrical connections were exposed, which allowed contact with the patient's skin. the ecri investigation of this incident revealed that the patient actually had a single use (disposable) spo2 sensor burn. anyway, the burn was not thermal, as it might have been suspect; was an electrochemical burn caused by low voltage, direct current (dc) tissue electrolysis that occurred at the location of the exposed electrical connections. the process of tissue electrolysis caused by the application of a health product, although rare, is well known and well documented (grossi et al., 1993; lepin et al., 1970 orpin 1982). saline electrolyses on the skin produce sodium hydroxide and hydrogen gas in the cathode (the negative electrode). this damages the skin, resulting in a whitish lesion under it. at the anode (the positive electrode), hydrochloric acid (hcl) is produced, along with chlorine gas and / or oxygen. these combinations cause a dark discoloration of the skin under and surrounded by the anode.
  • Action
    Electrochemical burns of SpO2 sensors can be prevented by not allowing damage to the sensor's electrical connection exposure to connect to a patient. Either way, it is important for health care professionals to inspect the sensor before it is placed on a patient or when it is moved to another location. Damaged sensors should not be placed on patient. This type of incident can occur with any SpO2 monitoring device (pulse oximeter or physiological monitor) when uninsulated electrical connections from a sensor are exposed to the patient's skin.

Device

All Pulse Oximeter Sensors
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA