The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning CARTOR 3 Systems manufactured by Biosense Webster, Inc. The manufacturer has recently become aware that some CARTO® 3 Systems may be susceptible to ablation radio frequency interference through certain interconnected cable configurations.
According to the manufacturer, the root cause has been determined to be a newly introduced Patient Interface Unit (PIU) Backplane card. The new card is more sensitive to radio frequency interference, which will manifest as a jumping/ disappearing icon and/or error messages 105 and 319.
Biosense Webster explained that while ablation at an unintended location could potentially happen as the result of undetected or ignored icon jumps, the likelihood of this happening is remote as the high detectability of icon jumps and the verification of catheter tip position with fluoro and/or ECG by operating physicians. As a result, the probability of a potential patient injury from icon jumps is unlikely and continued use of the CARTO® 3 Systems remains safe and effective.
Biosense Webster is going to replace the PIU Backplane card for the affected customers. Meanwhile, customers are suggested to eliminate the radio frequency interference by utilizing the accessories provided with the customer notification. The notification also suggests ways to deal with the error messages. For details, please refer to the following MHRA website: http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected product, please contact your supplier for necessary actions.