Events

Recall of SORIN CENTRIFUGAL PUMP CP5 SYSTEM - ENTIRE SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA CANADA CORP..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72977
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    During internal testing livanova identified a possibility that automatic line closure by the electrical remote-controlled tubing clamp (erc) after detection of an air bubble could take longer than is intended by design in the cp5 system. this could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the ifu (1 meter).

Device

SORIN CENTRIFUGAL PUMP CP5 SYSTEM - ENTIRE SYSTEM
  • Model / Serial
    Model Catalog: 60-00-60 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 60-02-60 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    SORIN CENTRIFUGAL PUMP CP5 SYSTEM;SORIN CENTRIFUGAL PUMP CP5 PUMP CONTROL PANEL
  • Manufacturer
    LIVANOVA CANADA CORP.

Manufacturer

LIVANOVA CANADA CORP.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    HC