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Defective Pediatric Intensive Care Catheter; Recall Affects 11 States


On March 30, 2015, OriGen Biomedical of Austin, TX, initiated a nationwide recall for one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen Biomedical is aware of at least one product failure and has received a complaint associated with the problem. This serious adverse event resulted in a patient death.

 

The OriGen VV13F Reinforced Dual Lumen ECMO Catheter is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less in Neonatal Intensive Care and Pediatric Intensive Care ECMO centers. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby. This system provides heart-lung bypass support outside of the baby's body.

 

The recalled product was manufactured on September 22, 2014, and distributed from February 16 to March 26, 2015. The recalled product was distributed to ECMO sites in eleven states.

 

See the Recall

 

See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability

 

See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe

 

See the Medical Law Perspectives February 23, 2015, Blog: Florida’s No-Fault Compensation System for Severe Birth Injury Claims Fails Again 

 

 

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