The Food and Drug Administration (FDA) and Baxter Healthcare, the manufacturer of the HomeChoice and HomeChoice PRO dialysis systems, have notified patients of a Class I device recall after a number of reported injuries and one death. Recalls receive Class I status when there is reasonable probability that a device or drug will cause serious injury or death.
The devices reportedly cause increased intraperitoneal volume (IIPV), which can result in serious injury or death from abdominal wall or diaphragm hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.
According to the FDA, the critically ill, patients with pulmonary and hemodynamic instability, children, and nonverbal patients are at greater risk of injury. Although the device is being recalled, the devices already in the market are not being removed. Healthcare professionals with the dialysis system should consider the risks of use or consider alternative dialysis therapies before treating patients, the FDA said in the release.
Patients who exhibit any of the following symptoms should cease using the device, start a manual drain, and contact a healthcare professional:
- Difficulty breathing
- Vomiting or spitting up
- Difficulties feeding
- Full, bloated, or overfilled feeling after treatment
- Abdominal pain or discomfort
- Expanded or tense abdomen
- Localized swelling of the genital area, groin, belly button, tunnel of the dialysis catheter, or catheter exit site
- Fluid leak from the catheter exit site
- Unexpected hypertension