The Department of Health (DH) received a notification from Baxter Healthcare Limited (Hong Kong) (Baxter) this afternoon (August 11) that it would organise with customers the return and replacement of an automated peritoneal dialysis system, HomeChoice (product code: 5C4474).
Baxter explained that the arrangement was necessary because the required final tests and calibration of the product model had not been performed, a spokesman for the department said.
Through network searching, the DH also noticed that the US Food and Drug Administration (FDA) had actually issued an alert earlier on this year concerning reports of serious injuries and at least one death linked to increased intraperitoneal volume (IIPV) associated with the use of the same model.
IIPV can cause serious breathing and heart problems which can result in serious injury or death.
In addition, children and nonverbal patients may be at increased risk because of their smaller abdominal cavities or inability to communicate.
According to Baxter, at least 186 HomeChoice devices had been affected in Hong Kong.
So far, the DH and Baxter have not received any report of adverse events related to this issue.
Taking into account the information available, DH is concerned with possible safety, efficacy and quality of the product, he said.
While seeking further clarification from FDA and the Baxter of two events, DH in fact instructed Baxter to recall and replace the device concerned.
"Patients using the device are urged to contact their attending doctors immediately," the spokesman said.
"As an interim, clinicians are advised to balance the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy.
"They should also review the prescription settings for patients who continue to use these devices," he said.
Baxter's local supplier has set up a hotline, 6113 1063, for public enquires.
The DH will closely monitor the progress of the recall.
Ends/Wednesday, 11 August 2010