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

Device Problem Nonstandard Device (1420)

Patient Problem Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

"ivt" call transferred from (b)(6), psr.Spoke with pt regarding cassette issue.Pt reported that he has 12 cassettes of 3 different defective lot numbers 3891159, 4321040, and 4298336.Pt has 1 cassette with lot# 4329622.Reviewed pt to use only that cassette until order is delivered on 12/20/2022.Patient reported change in breathing "felt like medication not doing it's thing'' 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?change in breathing; if yes, was any medical intervention provided? no is the actual product available for investigation? yes.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 alarm occurred is not applicable.No add'l info is available at this time.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: 16112926
• MDR Text Key: 306890219
• Report Number: MW5114192
• Device Sequence Number: 9
• Product Code: LHI
• Combination Product (y/n): N
• 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: 12/20/2022
• 12 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male