Safety Alert for VAMP Jr. Edwards Blood Collection Closed System, model VMP306, Anvisa Registration No. 80219050051, manufactured until 02/29/2008.

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.

Complaints were received by the manufacturer in February 2008. These three claims described blood return to the reservoir. In one of the three, the reservoir cap was disconnected during use of the product. The other two caps were disconnected during the investigation at the company. In the first complaint there was no report of damage to the patient, but a loss of 5 to 10 ml of blood was reported. The company's decision to collect the product is based on concern about the consequent blood loss in a population of pediatric patients who have low blood volume and the risk of infection. The events occurred in the US and all the steps as well as notifications to the FDA were made by the manufacturer Edwards Lifesciences. In Brazil, the product recall was initiated in March 2008 by Edwards Lifesciences CPMC Ltda.