The FDA and manufacturer of the HomeChoice and HomeChoice PRO dialysis systems have notified patients of a class I device recall — the FDA’s most serious — after a number of reported injuries and one 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.
The critically ill, patients with pulmonary and hemodynamic instability, children, and nonverbal patients are at greater risk of injury, the FDA said. Children are particularly at risk because of their small size and nonverbal patients because of their inability to communicate.
These populations should be monitored carefully, the FDA said.
Baxter Healthcare of Deerfield, Ill., says it has recalled HomeChoice products with the following codes: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D, 5C4474DR.
Also recalled are the following HomeChoice PRO models: 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R.
Although the device is being recalled, 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
Recalls receive class I status when there is reasonable probability that a device or drug will cause serious injury or death.