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 HOSPIRA HEALTHCARE CORPORATION.

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
    131590
  • Event Risk Class
    I
  • Event Initiated Date
    2015-06-25
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    Q core medical has identified a software issue with q core saphirre multi therapy and epidural pumps with each of the software version r11v53 change set 12333 12334 and 12998 that may create a potential risk of over-delivery in specific situations.No patient injuries or deaths have been reported as a results of this issue. however q core has determined there is a significant patient safety risk due to the potential for over-delivery.

Device

SAPPHIRE MULTI-THERAPY INFUSION PUMP
  • Model / Serial
    Model Catalog: 15032-000-0011 (Lot serial: N/A); Model Catalog: 15031-000-0001 (Lot serial: N/A); Model Catalog: 15031-000-0013 (Lot serial: N/A); Model Catalog: 15032-000-0001 (Lot serial: N/A)
  • Product Description
    Sapphire Multi-Therapy Infusion and Epidural Infusion Pumps
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC