Events

Alerta De Seguridad para All Pulse Oximeter Sensors

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    742
  • Fecha
    2003-09-17
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA