The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning the haemodiafiltration device, "HDF On-line" [Product code: M03831] manufactured by Medica S.p.A. The affected products are identified by the following batch numbers: PV13/0352, PV13/0398, PV13/0401, PV13/0440, PV13/0450, PV13/0457 PV13/0458, PV13/0469, PV13/0504, PV13/0508, PV13/0517, PV13/0518, PV13/0519, PV13/0536, PV13/0538.
The manufacturer has become aware that some HDF On-line units may have loose connections between the ultra-filter headers and the tubings. This may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment. Some HDF On-line units may have loose connections between the ultra-filter headers and the tubings which may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment.
According to the manufacturer, if fluid loss from a connector occurs during treatment and it is not detected, this event may cause a fluid imbalance in the patient, with the risk of excessive weight loss (hypovolemia). Another potential risk (this has never happened to-date and the probability of occurrence is remote) is the impairment of the sterile barrier which is ensured by the proper tightness of the connections, with the consequent need for medical intervention to prevent further complications.
The manufacturer advises all affected users to check the connections of the HDF On-line device are tightly screwed before and after use.
For details, please refer to the following link:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON377619
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 February 2014