Events

Safety Alert for IMPULSE SYSTEM OF PUMPS WITH PEDAL, MODEL 6060 KENDALL AV; WE. SERIES BELOW 72299, UNITS WITH CIRCUIT BOARD MARKED V2

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

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
    74
  • Date
    2001-05-18
  • 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
    One of the ecri member hospitals reported have found problems with these pumps with pedal, which had stopped to pump and was rebounded for standby mode, and recovered the pressure parameters in the low every vazque that the surgery acted the electrocirutric unit in the proximity, during an orthopedic surgery. the hospital also verified that the unit worked normally when it was away from the electrocirutric unit.
  • Action
    IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. KENDALL AFFIRMS THAT UPDATE V3, WHICH REPLACES V2 PLATE (PCB), HAS HIGHER PROTECTION AGAINST ELECTROMAGNETIC INTERFERENCE OF ELECTROCIRUTIVE UNITS. KENDALL RECOMMENDS THAT YOU WILL LEAVE THESE PRODUCTS WITH A V2 PLATE AT LEAST 1 METER DISTANCE FROM THE ELECTROCOURGICAL UNITS OR CONTACT KENDALL TO OBTAIN THE UPDATE SET THROUGH THE MAIL (ADDRESS: THE KENDALL CO, 15 HAMPSHIRE ST, PO BOX 9112, MANSFIELD MA 02048-9932, USA), BY FAX 0021-1-508-261-8582 OR BY PHONE 0021-1-508-261-6000. ECRI RECOMMENDS THAT (1) CHECK THE SERIAL NUMBERS, IF BELOW 72299, AND IF THIS PUMP WILL BE USED IN A SURGICAL BLOCK, CONTACT KENDALL TO OBTAIN UPDATE. (2) COLE, IN ANTIQUE PUMPS, WELL VISITED, THE LABEL IS THIS PUMP CAN NOT BE USED ON A SURGICAL BLOCK!

Device

IMPULSE SYSTEM OF PUMPS WITH PEDAL, MODEL 6060 KENDALL AV; WE. SERIES BELOW 72299, UNITS WITH CIR...

Manufacturer

ORTHOFIX CO. INGLATERRA
  • Source
    ANVSANVISA