MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD PUMP MS3; PUMP, INFUSION

Model Number 7400

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Headache (1880)

Event Type  Injury  

Event Description

Follow up.Cnss reports they just visited pt at (b)(6) hospital.Pt is hospitalized due to previously reported ms3 pump issue.Cnss reports they reprogrammed pt's working cadd ms3 pump and took the other pump that was giving message: call for service (previously reported - serial number unknown) with them so there would be no confusion about which pump was working.Pt currently only has 1 cadd ms3 pump in their possession (pharmacy pump replacement en route to pt).Cnss confirmed pt is on iv flolan in the hospital, current dose: 40.7ng/kg/min.Cnss reports pt is doing well for the most part; pt complains of migraines but all of their vitals looked good.Cnss reports pt's blood pressure was 105/60-something.Cnss confirmed that pt was not rotating between their ms3 pumps like they should have been and was only using 1 pump.Cnss also reports that they observed pt having a peripheral line in hospital; cnss asked nursing staff to put in for midline instead.Cnss reports that they were working on changing the pt.¿s line when cnss was there/getting ready to leave.Pharmacy will notify md.Sq remodulin ms3 pt.No additional info, details, or dates available.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when alarm occurred is unknown.Pump return tracking information is not available.Photographs were not provided.Did the reported product fault occur while in use with the patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual product available for investigation? no.Did we replace product? yes.Did the patient have a backup product they were able to switch to? no.Was the patient able to successfully continue their therapy? yes.Is the therapy life-sustaining? yes.Reported to cvs/caremark by: health professional.

• Brand Name: CADD PUMP MS3
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16645385
• MDR Text Key: 312541770
• Report Number: MW5116123
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 7400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female