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

Device Problems Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Patient reported that 5 cassettes were not able to be used due to a malfunction.She stated over the course of the month her husband reported that 5 cassettes were unable to be filled because the tubing was clamped/kinked where the safety clip was not allowing any medication/diluent to pass through it.Exact dates unknown.This occurred during the mixing process and did not occur while in use.No injury or adverse events to patient due to malfunction.The actual cassette is not available for investigation as they have been discarded.Exact lot numbers and expiration dates unknown.Patient was able to mix with another cassette and continue therapy.Unknown if md is aware.No other information provided at this time.Pump return tracking info is not applicable to event.Photographs were not provided.This is a continuous infusion set flow rate and volume delivered are unk.Position of pump when event occurred is not applicable to event.No add'l info is available at this time.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? no; did we replace the product? yes; reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15940585
• MDR Text Key: 305243942
• Report Number: MW5113688
• 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: 12/05/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female