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

Model Number 7400

Device Problem No Flow (2991)

Patient Problems Nausea (1970); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Patient stated she last filled cartridge on (b)(6) 2020 and pump showed running.Pump serial number (b)(4).Patient went to go change cartridge today and the volume in pump had not changed, concluding that patient has been dry since last change.Patient denied any error message or alarm from the pump.Patient confirmed that pump was running and completed delivery process.Patient stated she has felt sleepier.Patient restarted infusion using back up pump at 5:00 pm on (b)(6) 2020 and stated experiencing nausea and flushing.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient and clinical injury? yes.If yes, was any medical intervention provided? no.Is the actual device available for investigation? yes.Did we [mfr] replace device? yes.Did the pt have a back up device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD PUMP MS3
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10747607
• MDR Text Key: 213671274
• Report Number: MW5097481
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2020
• Patient Sequence Number: 1
• Patient Age: 59 YR