Events

Retiro De Equipo (Recall) de Device Recall CS 300 IntraAortic Balloon Pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Maquet Datascope Corp - Cardiac Assist Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77877
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-3087-2017
  • Fecha de inicio del evento
    2017-07-17
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158122
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, balloon, intra-aortic and control - Product Code DSP
  • Causa
    False blood back detection alarm and the ingress of fluids into the iabp affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
  • Acción
    On July 17, 2017, Maquet/Getinge distributed Urgent Product Recall Medical Device Field Correction and Response Form notices to their U.S. customers via FedEx. Urgent Field Safety Medical Device Field Correction notices were distributed to international customers via email and courier service. Maquet/Getinge advised affected customers to perform risk-benefit assessments with their respective medical team for each patient, when no alternative IABP or alternative therapy is available. Maquet/Getinge provided general information and overall action for the user informing them that: o The clinicians are instructed not to leave the patient unattended during IABP therapy pursuant to Warnings listed in the Operating Manual. o For Blood Detection Alarm - Until the service is performed, clinicians are instructed to follow the Blood Detection Alarm Help Screen found in the operating instruction to validate or clear the alarms. Maquet/Getinge recommends that users review the water condensation procedure (CS100/CS100i and CS300 IABP Operating Instructions section 3.4.1) to reduce the potential for condensation accumulation. In the event the IABP fails to successfully cycle and clear the alarm, remove the IABP from service and contact your local Maquet/Getinge Sales & Service Office. o For Fluid Ingression - Until the service is performed, Maquet/Getinge recommends customers review of the CS100/CS100i and CS300 IABP Operating instructions regarding cautions on placement of fluids and hanging of bags of fluid over the IABP. All facilities will be contacted by a representative of the Maquet/Getinge Service Team to schedule on-site service of your CS100/CS100i or CS300 IABP. Customers are advised to complete and return the Medical Device Field Correction Response Form. Please fax the completed form to 1-973-629-1690 or send via email to IABP2017TWO@getinge.com. If you a distributor has shipped any affected products to customers, please forward a copy of the docu

Device

Device Recall CS 300 IntraAortic Balloon Pump
  • Modelo / Serial
    0998-XX-3023-XX; 0998-UC-3023-XX
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS, NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM & YEMEN.
  • Descripción del producto
    CS 300 Intra-Aortic Balloon Pump. || It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.
  • Manufacturer
    Maquet Datascope Corp - Cardiac Assist Division

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division
  • Dirección del fabricante
    Maquet Datascope Corp - Cardiac Assist Division, 1300 Macarthur Blvd, Mahwah NJ 07430-2052
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA