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

Lot Number 4315908

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient reported she has 10 affected cassettes on hand: lots 4329615, 4315908 [expiration dates unknown].She has 1 cassette that is unaffected and is changing to that cassette today.Patient reported that alarm went off while using pump: "no disposable attached alarm".Patient switched cassettes and the alarm stopped.Patient did not know/was not able to report cassette lot number in use when alarm sounded.No interruption of treatment was experienced.Patient denies any shortness of breath or other symptoms at this time.Pharmacy to send replacement cassettes.No additional information at this time.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Setflow rate and volume delivered are unknown.Position of pump when alarm occurred is not known.No additional information is available at this time.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? no.Is the actual device available for investigation? yes.Did we [mfr] replace the device? yes.Did the pt have a backup device they were able to switch to? yes.If yes, was the pt able to successfully continue their therapy? yes; if the infusion life sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16086059
• MDR Text Key: 306608237
• Report Number: MW5114104
• Device Sequence Number: 2
• 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: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4315908
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female