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

Lot Number 4329615

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Red Eye(s) (2038)

Event Type  Injury  

Event Description

Spoke with patient for cadd cassette malfunction.Pt reports having #10 affected cassettes and 13 unaffected cassettes.Pt was able to change to an unaffected cassette while on phone with pharmacist.Pt reports that a few weeks ago, pt received an alarm on her pump when setting up a cassette but she doesn't remember what it said and she switched pumps and now reports both pumps are working fine and it hasn't happened since.Pt reports experiencing headaches and blood shot eyes starting last night.Pt denies any changes in breathing.Pt reports recovering from covid recently.Tested positive for covid on (b)(6) 2022 for covid and negative by (b)(6) 2022.No additional information at this time.Product lot number and exp date were systematically retrieved from the dispensing system.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? unk at this tim,; pt switched cassettes to unaffected cassette; is the actual cassette available for investigation? yes; did we [mfr] replace the cassette? 13 cassettes unaffected on hand; did the pt have add'l cassettes they were able to switch to? yes.If yes, was the pt able to successfully continue their therapy? 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 LEGACY CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16026437
• MDR Text Key: 306076133
• Report Number: MW5113905
• Device Sequence Number: 6
• 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: 12/16/2022
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4329615
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: OPSUMIT; PUMP; TUBING
• Patient Sex: Female