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Medfusion™ Syringe Infusion Pump Recall Lawsuit
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Any information that you send us in an e-mail message should not be confidential or otherwise privileged information. Sending us an e-mail message will not make you a client of Robins Kaplan LLP. We do not accept representation until we have had an opportunity to evaluate your matter, including but not limited to an ethical evaluation of whether we are in a conflict position to represent you. Accordingly, the information you provide to us in an e-mail should not be information for which you would have an expectation of confidentiality.
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.
Our Lawyers Are Ready To Assist You
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.
2 See https://www.smiths-medical.com/-/media/M/Smiths-medical_com/Files/Alerts/medfusion_software_anomalies_-_april_2022.pdf
RELATED PROFESSIONALS
Holly H. Dolejsi
Partner
Deputy Chair, Mass Tort, Personal Injury and Medical Malpractice Groups
Pronouns: she/her
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.