MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMING DISPOSABLE SET; WARMER, THERMAL, INFUSION FLUID

Catalog Number L-70

Device Problem Crack (1135)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.Device evaluation: one device and one photo were returned for investigation.Picture shows an l-70 device with original packaging.One unit was received in it's original packaging.Visual inspection found there was no evidence of delamination, damage or any discrepancies that could cause the failure mode reported.A leak test was performed.The unit passed the leak test.The reported failure mode was not confirmed.No root cause could be identified as the complaint was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken.

Event Description

It was reported that "before connecting the infusion set, it was noticed that there was a crack in the connection." the event occurred around mar-2024 in the facility.This occurred during priming, no patient involvement.No harm/adverse event reported.There was no disinfection or sterilization since unopened and unused, and no infectious disease occurred.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMING DISPOSABLE SET
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19169032
• MDR Text Key: 340964034
• Report Number: 3012307300-2024-02965
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: (01)30695085407007(17)270110(10)4337726
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L-70
• Device Lot Number: 4337726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1