MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE; SET, I.V. FLUID TRANSFER

Model Number 6400

Device Problem Pressure Problem (3012)

Patient Problem Anxiety (2328)

Event Date 12/31/2021

Event Type  Injury  

Event Description

Spontaneous.Pt reported currently receiving high pressure alarm on both cadd legacy pumps (serial numbers unknown).Pt changed cassette and tubing but high pressure alarm would not clear off either pump.Pt stated she will go to the hospital.No replacement pumps dispensed.Per follow-up communication from cnss (b)(6): "patient experienced 1cassette failure (lot number unknown).She was extremely nervous and did go to the hospital for her anxiety.The second cassette was working correctly but she was too nervous to resume her self care.Patient is now back home on the legacy pump with premix cassette.A cnss will be seeing her on monday ((b)(6) 2021) to mix a cassette from her emergency kit to supplement her weekly supply until premix refill is dispensed." prescriber has been notified.No other information known.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? no.Did we [mfr] replace device? no.Did the patient have a backup product they were able to switch to? yes, was the patient able to successfully continue their therapy? yes.Is the therapy life-sustaining? yes.Reported to (b)(6) by: patient/caregiver.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 13177089
• MDR Text Key: 283440975
• Report Number: MW5106486
• Device Sequence Number: 1
• Product Code: LHI
• 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: 12/31/2021

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 Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Patient Sequence Number: 1
• Treatment: CADD LEGACY PUMPS
• Patient Age: 49 YR
• Patient Sex: Female