August 2019

FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

• Volumat MC Agilia Infusion System and Vigilant Drug Library
• Models
  • Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
  • Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
• Lot Numbers: All
• Manufacturing Dates: All
• Distribution Dates: All
• Devices Recalled in the U.S.:
  • Volumat MC Agilia - 9,461
  • Vigilant Drug Library - 83
• Date Initiated by Firm: June 21, 2019

Reason for Recall
When enabled, the "Keep Vein Open (KVO), End of Infusion" alarm triggers when the infusion is complete. This results in the therapeutic rate of a medication changing to a non-therapeutic rate, as defined by the KVO rate. KVO alarms should be high priority. If a health care provider fails to respond to a "KVO, End of Infusion" alarm for a critical medication, a delay in care and/or under-infusion of medication can take place, which may lead to death or serious injury because the patient will be receiving a non-therapeutic rate of medication.

Fresenius Kabi will change their  "Keep Vein Open (KVO), End of Infusion" alarm from a "low priority" to a "high priority" alarm to ensure the health care provider knows the infusion has completed.  There has been one death reported outside of the United States related to a norepinephrine infusion where a health care provider did not adjust the "Volume to be Infused" after changing the drug bag and then did not notice the pump's "low priority" "KVO, End of Infusion" alarm. No other injuries have been reported in the rest of the world or in the United States.

Fresenius has also identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. These software errors could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these software errors.  

Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Certain Ellipse Implantable Cardioverter Defibrillators
• Lot Numbers: All lots manufactured between April 5, 2019 - May 29, 2019
• Model Numbers: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q
• Manufacturing Dates: April 5, 2019 to May 29, 2019
• Distribution Dates: May 6, 2019 to June 14, 2019 
• Devices Recalled in the U.S.: 108
• Date Initiated by Firm: June 20, 2019

Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices.  Of the devices recalled in the US, 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaints or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.