The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Hemodialysis Device DBB-06 and DBB-07 [Ref. No.: GE-F110-00, GE-F111-00, GE-F112-00, GE-F114-00 and GE-F115-00]. The date of manufacturing of the affected products were September 2012 and before
NIKKISO has received two complaints from a hospital technical department regarding too high a patient leakage current with the DBB-06 devices, used in combination with a central venous catheter (CVC).
The current is normally taken to ground via the earth conductor in the mains cable; however if the conductor is compromised the current will pass through the dialysate lines and dialyser to the central venous catheter and then to ground via any earthed surface the patient touches. Therefore, if the patient leakage current exceeds the recommendation of 10μA for type CF applied parts with a direct cardiac application there is a risk that the current could become concentrated at the catheter tip and could exceed the level that would induce ventricular fibrillation. Models DBB-06 and DBB-07 have a patient leakage current higher than that specified for type CF applied parts.
Apart from the two complaints mentioned above, no incident or complaint related to a too high patient leakage current was filed for both devices.
The manufacturer reminded users to consider that DBB-06 and DBB-07 devices may have additional risks in CVC treatment mode. Field service engineers of the manufacturer will modify the hardware of the DBB-06 and DBB-07 devices and check the compliance to the new established patient leakage current within the yearly standard preventive maintenance activities.
For details, please refer to the MHRA website as below:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON189227
If you are in possession of the affected product, please contact your supplier for necessary actions. .
Posted on 17 October 2012