Events

Rappel de Device Recall Maquet Cardiopulmonary Heater Cooler Unit HCU30 Type 2

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
    72652
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0589-2016
  • Date de mise en oeuvre de l'événement
    2015-11-13
  • Date de publication de l'événement
    2016-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141824
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Cause
    Failure of the heater-cooler unit (hcu 30) type 2 power supply board. a drop of more than 10% voltage can cause overheating and subsequent failing of the r56 thermistor of the power supply board. board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. this can shut down the compressor or the entire hcu 30 type 2 unit.
  • Action
    MAQUET sent "Product Recall Urgent Medical Device Field Correction" notices and "Medical Device Field Correction Response Forms" dated 11/13/2015 via UPS to affected customers. The notification identified the issue and how to identify the affected unit. The notification instructed customers to always keep a replacement heater-cooler unit on standby in the event of a unit failure; complete the attached Field Correction Response form (fax to 1.973.629.1518 or email to HCU30@maquet.com; and that they would be contacted by a representative of the Maquet Service Team to schedule an onsite service to determine if the power supply board in their HCU 30 Type 2 unit is affected adn replace the power supply board as necessary. If the customer had any questions they are instructed to contact their Maquet Service Representative or Maquet Technical Support at 1.888.627.8383 (Press option 3, followed by Option 1 and then option 1 again), Monday through Friday between the hours of 8:00 am and 5:00 pm.

Device

Device Recall Maquet Cardiopulmonary Heater Cooler Unit HCU30 Type 2
  • Modèle / numéro de série
    HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371 HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642 HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653 Heater Cooler Unit 30 with Serial Number <93101480  The affected power supply boards have serial numbers less than 107006001.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    United States Nationwide Distribution
  • Description du dispositif
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W || Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
  • 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