Events

Recall of PAINSMART IOD (AMBULATORY INFUSION PUMP)

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

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
    75256
  • Event Risk Class
    I
  • Event Initiated Date
    2011-03-20
  • 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
    There is the potential for a possible delay in therapy that may result during the use of software version 6r9 6r9a 6r9b 6r9c 6r9d and 6r9e. pumps programmed with previously mentioned software revisions may display a false error code 45 (motor condition loss of sync). this software anomaly renders the device in-operable until a recovery process is performed. recovery from error code 45 requires a power cycle of the pump during which the date time and all customized therapeutic parameters are lost. the recovery process requires all such parameters to be re-inputted by the clinician prior to beginning or resuming therapy.

Device

PAINSMART IOD (AMBULATORY INFUSION PUMP)
  • Model / Serial
    Model Catalog: 360-1300 (Lot serial: Contact manufacturer.); Model Catalog: 360-1300 (Lot serial: >10 serial numbers.); Model Catalog: 360-1300P (Lot serial: Contact manufacturer.); Model Catalog: 360-1200 (Lot serial: >10 serial numbers.); Model Catalog: 360-1200 (Lot serial: Contact manufacturer.); Model Catalog: 360-1300P (Lot serial: >10 serial numbers.); Model Catalog: 360-1400 (Lot serial: >10 serial numbers.); Model Catalog: 360-1100 (Lot serial: >10 serial numbers.); Model Catalog: 360-1400 (Lot serial: Contact manufacturer.); Model Catalog: 360-1100 (Lot serial: Contact manufacturer.)
  • Product Description
    PainSmart IOD (Ambulatory Infusion Pump)
  • Manufacturer
    ZEVEX INC.

Manufacturer

ZEVEX INC.
  • Manufacturer Address
    SALT LAKE CITY
  • Manufacturer Parent Company (2017)
    Moog Inc
  • Source
    HC