Events

Recall of PLUM A+3 INFUSION PUMPS

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
    26749
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-21
  • 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
    Hospira received reports related to distal pressure sensor calibration drift on plum a+ infusers. if the distal pressure sensor calibration drifted it will need to be recalibrated. the following error codes may be displayed during setup or infusion signifying possible calibration drift: e180/n e181/n181 e186/n186 e187/n187 or e346. additionally if the pressure sensor calibration has drifted user may expericence nuisance (false) digital occlusion alarms or distal occlusions that may not be detected. these errors invoke visual and audible warnings to the users.

Device

PLUM A+3 INFUSION PUMPS
  • Model / Serial
    Model Catalog: 20678 (Lot serial: All serial numbers); Model Catalog: 11005 (Lot serial: All serial numbers); Model Catalog: 20679 (Lot serial: All serial numbers); Model Catalog: 12391 (Lot serial: All serial numbers); Model Catalog: 20792 (Lot serial: All serial numbers); Model Catalog: 12618 (Lot serial: All serial numbers)
  • Product Description
    ALL PLUM A+/A+3 FAMILY OF INFUSERS
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

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