Iradimed Corporation is recalling its MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit. The MRidium 1145 Dose Reduction System (DERS) drug library kit is an accessory intended for use with the MRidium 3860+ Infusion Pump System.
The Dose Error Reduction System (DERS) can potentially give an incorrect recommended value for the pump infusion rate during the initial infusion setup. This is due to a specific key sequence when the override feature of the DERS drug limits is activated. A device malfunction can result in an increased risk of over-infusion or under-infusion if the infusion is started with this rate value. This can cause serious adverse health consequences, including death.
These products were manufactured from October 1, 2011, through June 27, 2013, and distributed from October 6, 2011, through June 28, 2013. The recall does not affect the following products:
- MRidium 3860+ Infusion Pump used without the DERS Kit,
- MRidium 3861 Infusion Pump Channel B accessory,
- MRidium 3865 Infusion Pump Remote Display accessory, or
- MRidium 3850 Infusion Pump products.
MRidium 3860+ Infusion pumps are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with fluids and/or medications into the vein or through the artery before, during, or after Magnetic Resonance Imagining (MRI) scans.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication