Events

Safety Alert for (B) Code 4440008 - EASYPUMP C-BLOC RA 400ML 2-14mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h . Lots Affected: (a) Code 4440006: Lot no. 142639 and (b) Code 4440008: Lot no. 152803 and 192472.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LABORATÓRIOS B. BRAUN S/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
    1233
  • Date
    2013-03-01
  • 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
    The company states that the I-Flow tests and the historical review of complaints have determined that about 0.04% of the pumps (4 out of 10,000 pumps) may have the described condition. If such a condition occurs, it may not be detected during the filling or priming of the pump. Anvisa follows this field action.
  • Reason
    When using i-flow elastomeric pumps with an on demand function, the bolus button may not lock in the lower position when pressed and either the orange bolus reset indicator may remain in the lower position. thus, the patient can receive continuous infusion at a flow greater than expected.
  • Action
    Immediate interruption of use of said products / lots; segregation thereof and information to B. Braun SA Laboratories of the quantities of existing units of each product code and batch number. Phone to contact: (21) 2602-3263 - jose.ricardo@bbraun.com.

Device

(B) Code 4440008 - EASYPUMP C-BLOC RA 400ML 2-14mL / h PCA 5mL / h PCA 5mL / h PCA 5mL / h PCA 5m...

Manufacturer

LABORATÓRIOS B. BRAUN S/A