Events

Rappel de PAINSMART IOD (AMBULATORY INFUSION PUMP)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ZEVEX INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75256
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2011-03-20
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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)
  • Modèle / numéro de série
    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.)
  • Description du dispositif
    PainSmart IOD (Ambulatory Infusion Pump)
  • Manufacturer
    ZEVEX INC.

Manufacturer

ZEVEX INC.
  • Adresse du fabricant
    SALT LAKE CITY
  • Société-mère du fabricant (2017)
    Moog Inc
  • Source
    HC