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

Model Number HL-90

Device Problem Failure to Power Up (1476)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event and d5:operator of device are unknown, no information has been provided to date.Device evaluation: one device was received for investigation.During visual inspection the device was observed to have a damaged display, missing reflux plug, enclosure with multiple scrapes and nicks, pole clamp with a damaged, non-conforming handle, quick connect corroded, water tank cover cracked, outdated circuit board and power supply.The reported issue was confirmed when the device line cord was found to have a small cut in the line, exposing wires.The investigation determined this condition would have resulted in the reported power issue.However, no root cause was established for this condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Due to the age of the device, it has been deemed beyond economical repair and will be decommissioned.

Event Description

It was reported that the device would not turn on.The issue was found during testing.There was no patient involvement and no patient harm or adverse event reported.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• 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: 18699945
• MDR Text Key: 335439229
• Report Number: 3012307300-2024-00778
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1