Events

Alerte De Sécurité sur SINGLE CHANNEL VOLUMETRIC INFUSION PUMP POWER CABLES, COLLEAGUE

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par BAXTER HEALTHCARE CORP.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    100
  • Date
    2001-04-24
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    BRAZIL, JANUARY 16, 2003: BAXTER HOSPITALAR INFORMES THAT THAT ACCORDING TO THE TECHNICAL SERVICE OF ITS COMPANY, THERE WAS NOT ANY OCCURRENCE THAT MENTIONED A SIMILAR CASE. ALSO NO OPENING OF ANY CALLS IN YOUR COMPLAINT SYSTEM. HAVING NO REGARD TO A SIMILAR CASE REGARDING NATIONALITY, BAXTER IS PROVIDED FOR OTHER CLARIFICATIONS. BRASIL, BRASILIA-DF, APRIL 24, 2003: BAXTER HOSPITALAR REPORTS THAT THE CORRECTIVE ACTION OF CABLES WAS NOT APPLIED TO BRAZIL, SINCE IT STARTED THE IMPORTATION OF THESE MACHINES SINCE THOSE EQUIPMENTS ARE BROUGHT WITH NEW CABLES. THE REFERENCE ACTION OCCURRED IN THE USA IN 2000 AND THE COMPANY STARTED IMPORTS OF THESE MACHINERY ONLY IN 2001.
  • Cause
    The manufacturer received reports regarding damage to the connection cables of the above infusion pumps mentioned. this damage may result in heating and potential burns from the area adjacent to the cable. the manufacturer began a correction by correspondence sent on april 24, 2001.
  • Action
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE SUBMITTED ON APRIL 24, 2001, THE INSTRUCTIONS FOR THE REPLACEMENT PROCEDURE AND THE BAXTER RESPONSE SHEET. IDENTIFY AND ISOLATE ANY AFFECTED PRODUCT IN YOUR STOCK. BAXTER RECOMMENDS THAT ALL POWER CORDS OF THE SINGLE COLLAGE CHANNEL PUMP BE REPLACED. BAXTER DECLARES THAT MOST RESISTANT CABLES WILL BE PROVIDED FREE OF CHARGE AFTER THE FILLING AND RETURN OF THE BAXTER RESPONSE SHEET BY FAX (847) 948-3948. BAXTER FURTHER INFORMES THAT THE IMMEDIATE RETURN OF THE RESPONSE SHEET WILL GUARANTEE THE INSERT OF THE CUSTOMER IN THE SUPPLY SCHEDULE. THE REPLACEMENT CABLES WILL BE IDENTIFIED BY THE "65 × 36" NUMBERS RECORDED IN THE ISOLATION COVER THROUGHOUT THE ENTIRE CAPE LENGTH. BAXTER RECOMMENDS THAT AFTER RECEIVING THE REPLACEMENT CABLE (S) THE USERS FOLLOW THE REPLACEMENT PROCEDURE INSTRUCTIONS MENTIONED IN THE CORRESPONDENCE AND (1) TRANSPORT THE PUMP BY THE PUMP LEVER AND NOT BY THE CABLE; (2) DISCONNECT THE WALL STRENGTH CABLE BY PULLING THE OUTLET AND NOT THE CABLE; AND (3) IF THE CABLE IS PACKED UP FOR TRANSIT / STORAGE, MAKE SURE IT ENOUGH CAPS AND IS PROPERLY PROTECTED. FOR FURTHER INFORMATION, PLEASE CONTACT THE SALES REPRESENTATIVE OF THE INFUSION SYSTEMS OR THE BAXTER SERVICE CENTER BY TEL. (888) 229-0001.

Device

SINGLE CHANNEL VOLUMETRIC INFUSION PUMP POWER CABLES, COLLEAGUE

Manufacturer

BAXTER HEALTHCARE CORP
  • Source
    ANVSANVISA