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

Lot Number 4163625

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Spontaneous email from (b)(6) field nurse who reported "i would like to report a product defect.Today during mixing (b)(6) cadd cassette, the tubing began to unscrew from the 50ml syringe by itself once it was tightened.It caused the diluent to leak when the patient attempted to inject diluent into the cassette." unknown if doctor is aware.No dosing information available since field nurse is still teaching patient the intravenous therapy.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? no.Is the actual device available for investigation? no.Did we [mfr] replace cassette? yes.Did the patient have a additional cassettes they were able to switch to? yes if yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? resolved.Resolved? yes, or ongoing? reported to (b)(6) by: health professional.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13290095
• MDR Text Key: 284187294
• Report Number: MW5106772
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4163625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male