Events

Rappel de Device Recall QUADROXi(D) Oxygenator

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 Maquet Cardiovascular Us Sales, Llc.

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
    62947
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0160-2013
  • Date de mise en oeuvre de l'événement
    2012-06-12
  • Date de publication de l'événement
    2012-10-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112151
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Cause
    It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of maquet oxygenators may detach from the oxygenator. this event has occurred in about 0.01% (1:10,000) of units shipped.
  • Action
    Maquet sent a Field Safety Notices and Confirmation Forms dated June 13, 2012 to all affected customers. A Follow-up communication dated July 20, 2012 was mailed to all affected US customers. The Field Safety Notice identifies the problem, affected product, risk factors and actions to be taken by the customer. Customers were instructed to complete the Confirmation form and return in the self-addressed prepaid envelop. For questions call 201-995-8968. Maquet issued an updated Field Safety Notice/Field Safety Notice Confirmation Form dated 2/14/13 via Fed Ex on 2/18/2013. Maquet sent out an Updated Field Safety Notice/field Safety Notice Confirmation Form dated 4/4/2013 in order to notify customers they would be providing safety clamps.

Device

Device Recall QUADROXi(D) Oxygenator
  • Modèle / numéro de série
    All sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895.   QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U.  HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050.  HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050.  Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX.  Note: an X was used to represent variations of catalogue numbers.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 || Product Usage: || The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA