AK 200 S and AK 200 Ultra S haemodialysis machines

Recall for product correction - Update to instructions to prevent blood loss if unit malfunctions

10 February 2015

An AK 200 Ultra S haemodialysis machine
An AK 200 Ultra S haemodialysis machine

Consumers and health professionals are advised that Gambro, in consultation with the TGA, has undertaken a recall for product correction to update the Instructions for Use (operator's manual) of its AK 200 S and AK 200 Ultra S haemodialysis machines.

Haemodialysis machines are used to remove toxins from the blood of people with kidney disease. Blood from the patient is pumped through the machine via tubing and returned to the body.

The operator's manual requires updating to account for circumstances in which one type of error alarm stops the unit from operating. This alarm will read as "ERROR! CALL SERVICE". The new instructions advise users to manually return blood to the patient if possible and stop treatment before contacting an authorised service technician to investigate the cause of the alarm.

The change to the instructions in the operator's manual follows three overseas reports of users sustaining blood loss of 400 ml and delays to treatment after an "ERROR! CALL SERVICE" alarm. There have been no reports of this issue occurring in Australia.

Information for consumers

Gambro has contacted the suppliers (primarily hospitals) of home use AK 200 S and AK 200 Ultra S haemodialysis machines to provide further information about the recall for product correction and instructions to notify all users of the change to the operator's manual.

If you, or someone you care for, uses an AK 200 S or AK 200 Ultra S haemodialysis machine and you have not been contacted by the hospital which supplied it to you with further information about this issue, or if you have any questions or concerns, contact Gambro on 1800 006 077 during office hours.

Information for health professionals and facilities

Gambro has contacted the suppliers (primarily hospitals) of AK 200 S and AK 200 Ultra S haemodialysis machines to provide further information about the above issue.

If you are treating a patient who uses an AK 200 S or AK 200 Ultra S haemodialysis machine advise them of this issue. If they have not been contacted by the supplier of their machine, or if they have any questions or concerns about this issue, advise them to contact Gambro on 1800 006 077 during office hours.

If you are responsible for supplying AK 200 S or AK 200 Ultra S haemodialysis machines to patients, please be aware of this issue. Contact affected patients and carers and notify them of the changes to the operator's manual.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.