The University of Iowa Hospitals and Clinics (UIHC) has sent letters to about 1,500 patients after at least one person who underwent surgery with a heater-cooler device was diagnosed a life-threatening infection.
Free Confidential Lawsuit Evaluation: If you or a loved one got an infection from a heater-cooler device, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the problem?
February 5, 2016 – So far, only one UIHC patient has been diagnosed with an infection associated with a heater-cooler device. The university has replaced their 4 older devices with new equipment since then, and officials say they’re confident the risk of infection has been eliminated.
“We regret that any patient within our care could be affected by this situation and apologize for any concern it causes,” UHIC said in a news release. “We are absolutely committed to making sure our patients have the information and care they need.”
Last October, the U.S. Food & Drug Administration (FDA) issued a Safety Communication warning about the risk of nontuberculous mycobacteria (NTM) infections linked to heater-coolers when used during cardiothoracic surgery. The warning came in response to at least 32 adverse event reports associated with the devices between Jan. 2010 and Aug. 2015.
In addition the warning, FDA has updated instructions for cleaning and maintaining heater-cooler devices. The Centers for Disease Control and Prevention (CDC) has also provided guidance on identifying patients with NTM infections.
A UI spokesperson said its facilities were exceeding manufacturer guidelines for disinfecting and maintaining heater-cooler devices prior to the FDA warning, and they’ve updated their protocol based on the new recommendations.
Due to privacy concerns, UI has released few details on the infected patient, and it is still unclear as to whether they’ve been treated and what type of procedure he or she underwent prior to developing the infection.
The patient was reportedly diagnosed on Jan. 19; the connection to the heater-cooler device was made the next day. By Jan. 23, the facility’s old equipment had been replaced, according to Theresa Brennan, cardiologist and chief medical officer for the UIHC.
The hospitals and clinics on Feb. 1 began sending letters to about 1,500 patients who may have been exposed to heater-cooler-related infections between Jan. 1, 2012 and Jan. 22, 2016.
Last October, the New York Times reported that at least 8 patients who underwent surgery with a heater-cooler device at WellSpan York Hospital in Pennsylvania had developed NTM infections. Of these, at least 4 patients died, although officials could not confirm whether the deaths were caused by the infections.
Do I have a Heater-Cooler Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently reviewing potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you got a heater-cooler infection, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.