Events

Rappel de MERLIN PATIENT CARE SYSTEM - PROGRAMMER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ABBOTT MEDICAL CANADA 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
    143412
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-10-11
  • 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
    A new management tool has been developed for clinicians to monitor patients who have devices subject to the october 2016 lithium cluster advisory to provide earlier notification of abnormal battery performance that may lead to premature battery depletion due to lithium cluster induced shorts. this tool will provide notification to clinicians via merlin.Net and upon interrogation with the merlin programmer to help identify voltage drops indicative of lithium clusters. the tool will be rolled out as a two part upgrade. the first upgrade is to merlin.Net (not a medical device) followed by merlin patient care system (pcs) programmer when the applicable software testing has been completed. refer to prior medical device advisory october 2016 for corrective measures implemented in association with the original advisory. in addition if a bpa alert is detected explant of the device is required.

Device

MERLIN PATIENT CARE SYSTEM - PROGRAMMER
  • Modèle / numéro de série
    Model Catalog: 3650 (Lot serial: N/A)
  • Description du dispositif
    MERLIN PATIENT CARE SYSTEM-PROGRAMMER
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC