SynchroMed® implantable drug pump 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

MHRA is aware of five incidents in the United Kingdom where the use of diamorphine solution has resulted in malfunction of the SynchroMed® pump. In four of these incidents, pump malfunction led to cessation of drug delivery (motor stalling) resulting in return of patient symptoms. In the remaining incident (still under investigation) pump malfunction led to over-infusion of diamorphine solution and the patient suffered a cardiorespiratory arrest.Failure analysis of the four cases of motor stalling by Medtronic has shown that motor stalling was associated with the long-term administration of diamorphine solution, where the materials of the internal components were damaged. Diamorphine (diacetyl morphine) in aqueous solution will degrade over time, producing an insoluble active compound (6-monoacetyl morphine), which is an acetate and is believed to have caused the damage to the pump.Current Instructions for Use for the SynchroMed® implantable drug pump do not include diamorphine in the list of medications that are compatible with the pump.In October 2002 Medtronic distributed an “Educational Brief: Revised Drug Formulation SynchroMed® Infusion System”, which listed drugs and additives known to be incompatible with the SynchroMed® implantable drug pump. Diamorphine was not included in this listing since its adverse effect had not been recognised at that time. To clarify this situation Medtronic plans to distribute further information shortly.It is estimated that there are 1200 SynchroMed® drug pumps currently implanted in the UK.