Specialist solicitors at Lime Clinical Negligence & Personal Injury are becoming increasingly concerned for patients who have undergone open heart surgery in the past few years after being instructed to represent a number of patients who have developed infections following their surgery, because of allegedly defective medical equipment, which heats and cools the blood during the procedure.
Public Health England (PHE), the Medicines and Healthcare Regulatory Authority (MHRA) and NHS England have conducted an investigation which found that the blood heating / cooling devices, manufactured by Liva Nove PLC (formerly Sorin Group Deutschland GmbH), were found to be the source of serious infections in patients.
The investigations revealed that a number of patients who had undergone cardiopulmonary bypass surgery later developed infections including Endocarditis, and Septicemia associated with Mycobacterium Chimaera. Endocarditis and Septicaemia are both types of infection which can cause long term and life changing ill health, and which can also prove potentially fatal. In some cases, the infections might take months or even years for patients to develop symptoms.
The Care Quality Commission (CQC) will now expect to be provided with evidence that providers of the units have complied with their responsibilities to minimise the risk of such infections. The CQC has placed a number of responsibilities upon the providers of the heater / cooler units, such as to ensure that the devices are microbiologically monitored according to the manufacturer’s instructions; to conduct local risk assessments to be reviewed annually and to be acted upon; that the units be positioned outside the operation theatre where possible and that any issues relating to the use of the heater / cooler units be notified to MHRA, NHS England or PHE.
In addition, the CQC has requested that all providers of acute care disseminate information to relevant clinical staff and to ensure that they have methods in place to diagnose mycobacterial and Legionella infections in patients and staff who have been exposed to the heater cooler units. Further, acute providers must ensure that they comply with the requirements for reporting of cases and heater / cooler unit related issues.
Lime’s specialist Medical Negligence and Product Liability Lawyers have been instructed by a number of patients who have been exposed to the heater / cooler units and who have subsequently developed signs and symptoms of infection. Our investigations are within their very early stages and we are currently in the process of gathering information to assess the appropriate course for personal injury litigation.
In most of the cases, which we have seen to date, our clients have received letters from their treating hospitals informing them of the above investigations to raise their awareness of any symptoms, which they might have developed, following their open heart surgery. These letters describe that the symptoms of infection might include:
- unexplained fever
- unexplained weight loss
- increased shortness of breath
- waking up during the night with heavy sweating
- joint or muscular pain
- nausea
- vomiting or abdominal pain
- abnormal levels of tiredness and fatigue
- pain, redness or pus around the surgical site.
Patients who have undergone open heart surgery in recent years who experience these symptoms have been encouraged to speak with their GP.
If you have undergone open heart surgery, such as cardiopulmonary bypass, and have since developed any of the above mentioned symptoms, or if you have received notification from your treating hospital or GP that these blood heater / cooler devices were used during your surgery, please get in touch on Freephone: 0808 164 0808 or complete the request a call back form and we will call you.
