Events

Rappel de Device Recall Insulin Infusion Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical MD, 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
    47423
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1591-2008
  • Date de mise en oeuvre de l'événement
    2008-02-22
  • Date de publication de l'événement
    2008-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69479
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Infusion Pump - Product Code LZG
  • Cause
    Smith medical has received reports of deltec cozmo¿¿ insulin pumps powering down without an alarm. investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. this may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. if a patient is asleep or does not regularly check their blood gl.
  • Action
    Consignees and the USA demonstration pump physicians were mailed an "Urgent Medical Device Correction" letter on 2/22/08. The letter stated Details on Affected devices, Description of the problem, Advice on action to be taken by the user, Additional Information and New Warning. These consignees will be required to return the Correction Confirmation Form. The 17 countries with international mailing addresses were sent the Urgent Medical Device Correction letter (Urgent Field Safety Notice) via the Smiths Medical International Regulatory department based in Watford UK. The Smiths Medical Distributors and Affiliates will be required to mail the Safety Notice to their direct users. The USA distributors were mailed the Urgent Medical Device correction letter with a cover letter. These consignees will be required to add the letter to in-house inventory. The USA prescribing physician and the the USA Managed Care Accounts (Insurance Companies) were mailed the Urgent Medical Device Correction letter with a cover letter. These consignees will not be required to respond and no follow-up will be done by Smiths Medical. Contact Mike Herbert at 651-628-7049 if you have any questions or did not receive the recall information from the firm.

Device

Device Recall Insulin Infusion Pump
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of AU, CA, CL, CN, DE, EG, FR, GB, GR, IL, KW, MX, NL, NZ, ON, PL, SA, SE, TR, UK.
  • Description du dispositif
    Deltec Cozmo¿¿ Insulin Pump, model 21-1800. || This is similar to the currently distributed Deltec Cozmo¿¿ Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. || Reorder Numbers: || 21-1801-81 || 21-1803-81 || 21-1804-81 || 21-1805-49/51/81 || 21-1806-49/51/81 || 21-1807-49/51/81 || 21-1815-01/50 || 21-1816-01/50 || 21-1817-01/50
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Adresse du fabricant
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA