Possible fire hazard with Formula kidney dialysis machines manufactured by Bellco

Starting date:

October 20, 2016

Type of communication:

Advisory

Subcategory:

Miscellaneous, Medical Device

Source of recall:

Health Canada

Issue:

Physical Hazard, Medical Devices

Identification number:

RA-60654

• Issue
• What you should do
• Media enquiries
• Public enquiries

Issue

Health Canada is advising Canadians that Formula kidney dialysis machines manufactured by Bellco may pose a potential fire hazard. According to the company, the chance of a fire occurring is low and patients should continue using their machines for dialysis treatment until service technicians can take the appropriate safety precautions.

The following machines are affected:

Device Name	Model Number
Formula	IBFXMX700 IBFXMX301 IBFXMX300
Formula 2000	IBFXBX700 IBFXBX301 IBFXBX310
Formula 2000 DOMUS	IBFPBD37D IBFXBD301 IBFXBD310
Formula 2000 PLUS	IBFPBX37D IBFPBX301 IBFPBX310
Formula 2000 PLUS DOMUS	IBFPBD301
Formula DOMUS	IBFXMD301 IBFXMD310
Formula Therapy	IBFTBX301
Formula Therapy DOMUS	IBFTBD301

Dialysis machines are used by patients suffering from chronic kidney failure.

To date, three fires have been reported in three separate machines: one during a cleaning cycle, and two before patient use when the machines were switched ON. In all three cases, no patients or healthcare providers were injured. Investigations have found that the battery charge board was the source of two of the fires, and likely the source of the third.

Bellco is advising all affected customers, via couriered mail, of the risk and providing them with instructions for their service technicians to disconnect the battery charge board to eliminate the possibility of malfunction. Bellco will also be directly contacting providers of homecare patient programs by phone to ensure they have received the necessary instructions. Disconnecting the battery charge board is a temporary solution, and does not affect the performance of the machine. Bellco is working to find a more permanent solution to prevent a possible recurrence.

Bellco will communicate further direction with all customers once a permanent solution is confirmed.

What you should do

• Contact the healthcare provider who administers your dialysis to find out whether you have an affected machine.
• Report complaints about health products to Health Canada by calling toll-free to  1‑800‑267‑9675, or complete an online complaint form.

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Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709