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

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.

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 http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2007/895_1.pdf 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.