Events

Safety Alert for N VISION MEDTRONIC PROGRAMMER - Model 8870 Application Software Cards used with N Vision Clinician Programmers Model 8840, Reg # 10339190180.

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

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
    785
  • Date
    2004-09-24
  • 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
    In Brazil - The company informs that no card was imported until the precious moment. Only 06 units of the N Vision Clinician Model 8840 programmer were imported in August 2004 but have not yet been used as there are no 8870 software application cards available. It further informs that this recall is limited to software application cards and does not include other equipment and accessories and no action to patients on this recall is required. Clarifies that it has developed a software replacement version AAA02 that provides additional information and clarifications of the time intervals designed to assist the user in the risk of error in data entry. These software application cards were distributed from December 2002 to May 2004. As of May 2004 Medtronic Neurological no longer distributed these cards. For more information, contact Medtronic by telephone at the above number or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
  • Reason
    Medtronic has received overdose notifications associated with the use of the above-mentioned software cards when users mistakenly enter the periodic bolus interval value in the minutes field instead of entering them into the programmer's hours field. 4 patients with serious injuries and 2 deaths may have resulted from this problem. the manufacturer declares that this subject is limited to software cards when they are used to program synchromed and synchromed el pumps and does not include sybchromed ii pumps or any other equipment. the company has developed replacement software to reduce the risk of error in data entry. the manufacturer started a recall by letter dated august 2004 and states that half of the affected software cards were replaced in early august 2004.
  • Action
    Check receipt of the letter dated August 2004, two attachments and Medtronic acknowledgment form. Identify and segregate any affected product in your inventory. Remove the infusion pump scheduler application card, and identify it with the software version following the instructions in attachment 1. If you have card programmers with software in AAA version 02, proceed as follows: (1) Complete the acknowledgment form, and return it by mail to Medtronic at the address below. (2) Contact Medtronic at (800) 328-0810, ext. 88608, USA or your local Medtronic representative outside the US to notify you of the number of affected cards in your inventory and to request updated versions. (3) Upon receipt of the updated cards, return the old cards to Medtronic by mail at the address below using the shipping envelope provided. If you need to use the infusion pump programmers before completing this recall, make sure during programming that you have selected the appropriate time field when entering the duration time or the interval time following the instructions in annex 2. If you already have AAD 02 version software updated on your infusion pump scheduler, or if you no longer have any affected products in your inventory, complete the recognition form, and return it to Medtronic by mail at the address below. Re-insert the AAD 02 card application following the instructions in Appendix 1, and continue using it. For more information, contact Medtronic by telephone at the above number or your local Medtronic representative.

Device

N VISION MEDTRONIC PROGRAMMER - Model 8870 Application Software Cards used with N Vision Clinicia...

Manufacturer

Medtronic Inc
  • Source
    ANVSANVISA