Alerta De Seguridad para Trima Accel Kit for Automatic Collection of Deleucotized Blood Components - registration number 10395890039.. Kit ELP 5 days for Deleucotized Platelets - reg. nº 10395890019

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por GAMBRO BCT, INC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Gambro BCT is receiving reports of leaks occurring near the spike in the secondary platelet bag in the COBE Spectra ELP and Trima Accel kits. The secondary platelet bag is one that does not have the sample collector. The leak is very small and occurs consistently in the same location. These leaks are observed during both the procedure and post-harvest. You may notice a small, slow drip near the spike connection port in the secondary platelet bag at any time during collection or post-collection. In approximately 60% of the leakage reports, the user observed leakage after collection. Gambro BCT performed a health risk analysis related to this problem. Leakage, as well as the presence of bacteria, may not be detected. If the product is transfused it can result in a transfusion reaction due to bacterial contamination, which can lead to a risk of death. The overall probability of occurrence of this severe reaction is extremely low, estimated at less than 1 / 1,000,000 transfusions. This problem does not affect the primary bag of platelets nor the accessory bags, since they are produced in other equipment. Spectra therapeutic COBE kits (TPE, WBC, AutoPBSC, RBCX) were also unaffected by this problem because they did not contain the secondary platelet pocket. In addition, the collection bag with two spike entries in the WBC kit are produced on different equipment. Access the link for information on batches and User Guidelines. Update: on January 2, 2008, the company reported that 6276 kits were imported, of which 5461 were distributed and 815 were segregated. It also informed that all customers have been advised and that they have undertaken to take the necessary preventive measures in order to avoid risks, these solutions include informing immediately to Gambro requesting the replacement of the Kit if it is verified that, after opening the Kit code 12 / 4 in the secondary bag. So far there has been no request for replacement. According to the company, the probability of future occurrence of tranfusion reactions due to this problem is eliminated when the customer follows the guidelines sent in the letter with Partial Recall title of the Kits Cobe Spectra ELP and Trima Accel. However, they inform that they will carry out periodic follow-ups on the customers until they no longer have the potentially affected kits in stock. / / Update on 05/12/2008: According to the company, up to now, 7 kits have been returned because they have the same defined characteristics in the recall. There are still 132 units to be returned and, due to the partial nature of the recall, it is estimated that it will take another 90 days for the customer to verify the product and make the return, if applicable. The lots that have been returned are in the customs zone awaiting clearance for shipment and return.
  • Causa
    Leakage in the secondary bag of platelets.
  • Acción
    The Gambro BCT engineering team performed a cause-of-issue analysis, implemented corrective and preventive actions, and identified the products that may have this problem. The cause of the problem was identified as being weak welding of the secondary platelet pocket, which occurred due to a combination of factors during the manufacturing process. This defect occurred randomly in only one of the 24 molds used to produce the secondary platelet bag in automatic production equipment. Gambro BCT has implemented corrective actions already in the kits produced from August 2007 (sterilization date of August / lot number 08Nxxxxx), with the exception of lot number 08N9101.


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