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

Lot Number 3630794

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2018

Event Type  malfunction  

Event Description

Pt states cassette sn (b)(4) the bladder is "shrunk in" and the neck doesn't dispense liquid.She provided photo images to cnss john-cadd ext tubing lot number 3648274.Has air bubbles and the filter is not filling with liquid (previously reported issue from this patient) and per unsolicited email from the field nurse: patient phoned me to say that lately she has been having trouble with leaking iv extension tubings, sent patient a new lot number to try- no further information available.Dose or amount: na, frequency: continuous, route: intravenously.Diagnosis or reason for use: i27.0, pah.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7934044
• MDR Text Key: 123071547
• Report Number: MW5080333
• Device Sequence Number: 1
• 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: 09/18/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3630794
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR