By Joe Messa
A heater-cooler device used to control the temperature of patient’s blood during cardiopulmonary bypass procedures at WellSpan York Hospital might be to blame in the death of four patients and the infection of at least four others.
The device in question is manufactured by Sorin Group, (now LivaNova) a medical devices manufacturer based in Italy. Sorin Group released a statement claiming that after an internal review, it was clear that the hospital’s cleaning procedures did not meet Sorin guidelines for disinfecting the device. WellSpan Senior Vice-President, Dr. Hal Baker, said that the device doesn’t make direct contact with the patients and therefore, “people really didn’t see it as a source of infection.” According to the U.S. Food and Drug Administration (FDA), however, contaminated water has the potential to enter other parts of the device or to transmit bacteria through the device’s exhaust vent, into the air, and to the patient.
A WellSpan press release related that the issue with the device is limited to only York Hospital and open-heart surgical patients at other WellSpan facilities were not affected.
York Hospital performed approximately 1,300 open heart procedures with the heating-cooling device between October 2011 and July 2015. The bacterium believed to be spread from the use of the device is a nontuberculous mycobacterium, or NTM. It is typically not harmful but can cause infections if exposed during invasive surgical procedures. Fortunately, the bacterium is easily treatable with antibiotics once identified. Unfortunately, it is a slow-growing bacteria and often takes several months to develop and possibly years to diagnose. As a precaution, York Hospital is sending letters to all 1,300 patients that underwent open-heart procedures between Oct 2011 and Jul 2015.
Patients potentially infected by the bacterium should look out for symptoms including fever, signs of infection around surgical incision, weight loss, night sweats, joint and/or muscle pain, and fatigue/loss of energy. WellSpan created an internet resource for patients with questions at www.wellspan.org/yorkopenheart. Nurses are also available to answer questions 24 hours a day at 866-217-2970.
WellSpan has promised to pay any costs associated with treating infections stemming from open-heart procedures performed at York Hospital.
The team of Philadelphia personal injury attorneys at Messa & Associates is highly experienced in handling dangerous drug and medical device cases. Firm founder, Joseph L. Messa, Jr., has earned multiple seven-, eight-, and nine-figure verdicts and settlements for clients injured by defective drugs. Firm partner, Eric H. Weitz, served as co-counsel on Topamax mass tort cases in Philadelphia that earned over $14 million for victims of Topamax-related birth defects.
Messa & Associates is armed with the right attorneys and the necessary connections to successfully litigate defective drug and medical device claims. If you or a loved one has become infected by the bacterium associated with York Hospital’s open-heart procedures, contact an attorney from Messa & Associates. Call 1-877-MessaLaw for a free consultation or submit an online inquiry for a free case evaluation.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More