Infected Surgical Device Killed Husband, Man Claims
1-18-2018 00:44:00

LOS ANGELES (CN) - A Kaiser patient died after being infected by a medical device during a 2015 open-heart surgery, his husband claims in a lawsuit filed in the Los Angeles Superior Court Central District.

Henri Paul Faucher, individually and as successor in interest to Carl J. Maravilla, decedent, sued for product liability regarding the Sorin 3T Heater-Cooler device for design defect, manufacturing defect and failure to warn; negligence; medical malpractice; wrongful death and loss of consortium.  
Defendants are: Livanova Deutschland; GMBH, fka Sorin Group Deutschland GMBH; Livanova Holding USA Inc., fka Sorin Group USA Inc.; Kaiser Foundation Health Plan Inc.; Kaiser Foundation hospitals and Southern California Permanente Medical Group
The Sorin 3T is a pump that circulates water through other devices to cool and heat a patient during open-heart surgery. The water is not meant to come into contact with the patient, but it can become aerosolized, leak out, or move by some other means to the surgical site, and it is impossible to properly and consistently sanitize the device, according to Faucher's complaint. 
Defendant device manufacturer continued making it after a Mycobacterium chimaera outbreak allegedly associated with its device began in 2011, and after itself finding contamination on the production line and water supply of its Munich, Germany factory in 2014, according to Faucher.
The device used in Maravilla's surgery came from the Munich factory, and when he died, he had in his system the same rare bacteria found at the factory and in other 3T devices, the complaint states.
Turning to the Kaiser defendants, despite a U.S. Center for Disease Control's Oct. 13, 2016, health advisory to alert patients such as Maravilla who may be at risk of M. chimaera infection due to exposure to the Sorin 3T during open-heart surgery, Kaiser did not bring it up when he re-entered the health system Oct. 15, 2016, with early symptoms, Faucher claims.
In fact, by the time Maravilla started appropriate antibiotic treatment he was in multisystem organ failure, from which he never recovered, the complaint states.
Faucher is represented by Khaldoun A. Baghdadi and Jasleen Singh of Walkup, Melodia, Kelly & Schoenberger in San Francisco and Michael K. Johnson, Kenneth W. Pearson and Leland P. Abide of Johnson Becker in St. Paul, Minnesota.