Events

Recall of SAPPHIRE MULTI-THERAPY INFUSION PUMP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by Q CORE MEDICAL LTD..

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
    20454
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-07
  • 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
    When using epidural mode with patient bolus the amount of medication delivered may be greater than programmed. in the sapphire pump as in all infusion systems external factors may cause fluctuations in flow rate accuracy.

Device

SAPPHIRE MULTI-THERAPY INFUSION PUMP
  • Model / Serial
    Model Catalog: 15032-000-0011 (Lot serial: 163116501); Model Catalog: 15031-000-0001 (Lot serial: 163113601); Model Catalog: 15031-000-0013 (Lot serial: 163116501); Model Catalog: 15031-000-0001 (Lot serial: 163116501); Model Catalog: 15032-000-0011 (Lot serial: 163121303); Model Catalog: 15032-000-0001 (Lot serial: 163121303); Model Catalog: 15031-000-0013 (Lot serial: 163121303); Model Catalog: 15031-000-0001 (Lot serial: 163121303); Model Catalog: 15032-000-0011 (Lot serial: 163121301); Model Catalog: 15032-000-0001 (Lot serial: 163121301); Model Catalog: 15031-000-0013 (Lot serial: 163121301); Model Catalog: 15031-000-0001 (Lot serial: 163121301); Model Catalog: 15032-000-0011 (Lot serial: 163123601); Model Catalog: 15032-000-0001 (Lot serial: 163123601); Model Catalog: 15031-000-0013 (Lot serial: 163123601); Model Catalog: 15031-000-0001 (Lot serial: 163123601); Model Catalog: 15032-000-0011 (Lot serial: 163126501); Model Catalog: 15032-000-0001 (Lot serial: 163126501); Model Catalog: 15031-000-0013 (Lo
  • Product Description
    SAPPHIRE MULTI-THERAPY INFUSION PUMP
  • Manufacturer
    Q CORE MEDICAL LTD.

Manufacturer

Q CORE MEDICAL LTD.