Overview
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Robins Kaplan LLP is investigating serious injuries related to Smiths Medical Medfusion™ 3500 and 4000 Syringe Infusion Pump recall.
On April 19, 2022 Smiths Medical issued an Urgent Medical Device Correction recall1 for certain lots of pumps that were used between October 2004 and April 2022. Over 118,000 devices have been recalled in the U.S. due to software and hardware malfunctions.
These syringe infusion pumps are used in neonatal and pediatric hospitals, hospital operating rooms, and intensive care units (ICUs) to administer precise doses of medication, anesthesia, antibiotics, blood, and other therapeutic fluids to patients. Malfunction of these devices may cause overdosing, underdosing, or a delay in delivering life-saving medications to patients.
The FDA has identified this as a Class I recall, which is the most serious type of recall. The multiple issues identified with the infusion pump devices2 have been associated with serious injuries or death.
Reason for Recall
Eight software malfunction issues have been identified with certain lots of Medfusion™ 3500 and 4000 Syringe Infusion Pumps:
- False alarm for Primary Audible Alarm (PAA) system failure
- Unanticipated Depleted Battery Alarms
- Abnormal circuit board behavior, which may cause internal clock system failure
- Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues after system failure
- Unanticipated clearance of ‘Program Volume Delivered’ (PVD)
- False alarm for ‘Rate Below Recommended Minimum for Syringe Size’
- Incorrect bolus or loading dose time display
- Network configuration may affect pump communications.
Who May Have Be Affected
- Neonatal patients
- Pediatric patients
- Operating room patients
- Intensive care unit (ICU) patients
We Will Evaluate Your Case for Free
If you or a loved one have been harmed or injured by overdosing, underdosing, or a delay in medication given intravenously while in a hospital ICU, emergency room, pediatric hospital, or neonatal unit, you may be entitled to additional compensation.
Contact our attorneys for a free case evaluation at 1.800.553.9910 or by completing our online contact form above.
About Our Mass Tort Attorneys
Robins Kaplan mass tort attorneys understand the significance of each individual's experience in cases involving defective drugs or medical devices.
Our clients do not walk alone. We guide clients through the ins-and-outs of their case and help them understand the legal landscape as well as each step along the way. Our on-staff legal nurse consultants are available to answer your questions and listen to your concerns as you determine what to do next.
1 See https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may
2 See https://www.smiths-medical.com/-/media/M/Smiths-medical_com/Files/Alerts/medfusion_software_anomalies_-_april_2022.pdf
