The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device safety alert concerning Plum A+ Family of Infusers manufactured by Hospira UK Limited. The affected list numbers are:
According to the manufacturer, there is a potential for the Plum A+ fluid shield diaphragm to be out of specification and cause N250"Door Open while pumping" or N100"Unrecognisable Cassette" alarms. These alarms invoke audible and visual warnings to the user, which may occur during setup, infusion or Performance Verification Testing and will cause the device set up to be interrupted or the infusion to stop.
Hospira explained that if these alarms occur whilst the clinician is setting up the pump or an infusion is in progress, a delay or interruption in therapy may result. The severity in the delay or interruption in therapy is dependent upon the underlying condition of the patient and the treatment being prescribed. A delay or interruption in therapy has a worst case potential to result in significant injury or death.
To correct this issue, in September 2012, Hospira implemented a screening process to identify out of specification diaphragms at their manufacturing and service centres. Plum A+ devices shipped since that point successfully went through this screening process and have diaphragms that are within specification. Additionally Hospira is working with the supplier to ensure all future parts are manufactured within specification. Hospira will be contacting the customers to arrange for screening and if necessary replacement of any out of specification diaphragms.
Meanwhile, in order to prevent the occurrence of N250 and N100 alarms, Hospira advised the affected customers to take the following steps, as detailed in the Plum System Operating Manual (430-95597-008 B, 2012-11), regarding the insertion of the cassette.
In addition, if the unrecognisable cassette alarm (N100) occurs during the cassette loading process prior to infusion, Hospira recommended the affected customers to remove the cassette and attempt to reload the cassette again. If this action does not resolve the alarm issue, it is recommended that an alternative pump be used to minimise delay in patient treatment. If either the N250 or N100 alarm occurs during the infusion, users should safely remove the set from the pump (clamp the line before removal, as detailed in the System Operating Manual) and continue the infusion with another Plum A+ Pump. In either case, users should isolate the affected pump so that it can be tested away from the patient environment with new tubing set. If the problem continues, the pump should be removed from active service. This case should then be reported to the local Hospira office.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON226996
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 05 February 2013