Events

Rappel de Device Recall Baxter SPS 550 Hemodialysis Machine

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 Baxter Healthcare Corp..

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
    25607
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0660-03
  • Date de mise en oeuvre de l'événement
    2003-02-20
  • Date de publication de l'événement
    2003-03-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-03-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26144
  • 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
    System, Dialysate Delivery, Single Patient - Product Code FKP
  • Cause
    Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (tmp).
  • Action
    Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure. The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed. Changes to the instructions for use are in process and will be sent to the end users when completed. Additionally, the Baxter 1550 has a side panel that contains a 16-digit display. Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'. To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs. The SPS 550 does not have the side panel display and does not require the software upgrade.

Device

Device Recall Baxter SPS 550 Hemodialysis Machine
  • Modèle / numéro de série
    catalog numbers 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797;all serial numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.
  • Description du dispositif
    Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, Renal Division, 1425 Lake Cook Road, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA