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

Device Problem No Flow (2991)

Patient Problem Malaise (2359)

Event Type  Injury  

Event Description

Spontaneous call from pt.She switched to pump serial number (b)(4) on (b)(6) at 8:30 a.M.When she changed her cartridge.The pump indicated it was running but when she checked it 24 hours later, the cartridge was full, so she received no medication during that time.Pt has already notified nurse and doctor who are checking back in on her in an hour and if her status worsens she will go to hospital.Unknown outcome.(b)(6) is replacing pump today and will retrieve the malfunctioning one.She noticed the cartridge was still full the next day, as the malfunctioning pump was in use and didn't provide her dose.Patient was able to switch to her backup pump successfully and continue the infusion.Issue is thought to be patient or pump related, not cassette.Patient reported feeling "clammy and lousy".No additional information provided at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD MS3 PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; minneapolis MN
• MDR Report Key: 11663927
• MDR Text Key: 245562716
• Report Number: MW5100755
• 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: 04/08/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2021
• Patient Sequence Number: 1