Events

Rappel de Device Recall CADDSolis ambulatory infusion pumps

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 ASD, 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
    54482
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1082-2010
  • Date de mise en oeuvre de l'événement
    2010-01-27
  • Date de publication de l'événement
    2010-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88564
  • 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
    Pump, infusion, pca - Product Code MEA
  • Cause
    Potential for the power cord's prongs to crack and fail at/or inside the plug. other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. smiths medical has received no reports of incidents regarding the use of the affected electri-cord power cords with their devices.
  • Action
    Consignees were sent a Smiths Medical, Inc. "Urgent Medical Device Recall" letter dated January 27, 2010. The letter was addressed to Risk/Safety Managers, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Nenatologists, and Nursing, Pharmacy, Clinical/Biomedical Engineering, and Anesthesia Professionals. The letter described the problem, products involved and provided "Advice on Action to be Taken by the User". Consignees were requested to complete and return the "Urgent Recall Notice Confirmation Form". To return Power Cords, for questions regarding the recall notice or to report any issues with the affected product, please contact the Smiths Medical Technical Service Department at 1-800-558-2345.

Device

Device Recall CADDSolis ambulatory infusion pumps
  • Modèle / numéro de série
    Lot # 0068858-1-1.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States (KY and OH) and Canada.
  • Description du dispositif
    Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD¿¿-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. || Electri-Cord AC Power Cords are accessories for use with the CADD¿¿-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD¿¿-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Adresse du fabricant
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA