Events

Safety Alert for Trade Name: INTRA-AORTIC BALLOON PUMP Technical Name: Intra-Aortic Balloon Pump System ANVISA Registration Number: 10390690062 Hazard Class: III Model Affected: CARDIOSAVE Hybrid; CARDIOSAVE Rescue Serial numbers affected: 150468904PE and 150470604PE

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA..

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
    2256
  • Date
    2017-04-03
  • 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
    Before using IABP CARDIOSAVE, be sure that the 02 (two) lithium-ion batteries are fully charged and properly installed in the IABP console. Each fully charged battery can provide at least 1 (one) hour of operating time from IABP to 120 BPM. Do not carry spare batteries during transportation. In these transport operations, an AC Power Inverter for Transport is required to ensure continuous AC Power when the batteries are depleted. If an inverter and an AC Power Supply are not available, do not use the IABP for transport operations. Please note: The 02 (two) CARDIOSAVE lithium-ion batteries, once properly installed in the IABP, are not affected by the damage tax due to the fall. CARDIOSAVE lithium batteries are replaced every 04 (four) years or when the operating time is less than 60 minutes per battery at 120 BPM. Refer to the Operating Instructions / User Instructions for further details / information. A Maquet Representative will arrange an on-site visit to correct the "Do not Drop" label on the battery and provide additional instructions that will indicate extra care to avoid battery dropping. In addition, we are in the process of providing a reusable storage and transport box that will allow the transportation and storage of spare batteries. As soon as possible, we will ship these reusable boxes to you, free of charge, for each battery located in your unit. Future shipments of Maquet's CARDIOSAVE lithium-ion batteries will be shipped with this reusable container for shipping and storage. For transportation operations, do not charge spare batteries until you are provided with a reusable carton for transportation and storage.
  • Reason
    Maquet continuously monitors the performance of the cardiosave iabps and has discovered a problem that could affect the lithium-ion battery used with the iabp cardiosave. if the lithium-ion battery drops accidentally, the impact may cause the battery to vent. in addition to the hazards contained in the warning section of the operator's instructions / user instructions, battery venting presents the potential risk of generating smoke, strong unpleasant odor and sparks. it is important to note that to date there have been no reports of hazards or adverse events attributable to this problem to the patient. of a total of more than 8,000 lithium-ion batteries distributed worldwide, to date, there have been 3 reported battery venting incidents when falling.
  • Action
    Field Action Code - triggered under the responsibility of the company MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA. Company will make correction in the field.

Device

Trade Name: INTRA-AORTIC BALLOON PUMP Technical Name: Intra-Aortic Balloon Pump System ANVISA Reg...

Manufacturer

MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA.
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA