MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One level 1 low flow fluid warming system was received leaking water from the tank cover.The device was visually inspected, the tank was filled with water, a temperature check was attached, the line cord was plugged and the device was turned on.The reported leaking issue was able to be duplicated.The tank cover leaked a little bit, but there was no sign of any residue in the container.The reported residue must have to do with the water or type of fluid they used in the reservoir.The leak was caused by a small crack in a corner of the tank cover.The tank cover and gasket will be replaced to resolve the issue.

Event Description

Information was received indicating that a smiths medical level 1 low flow fluid warming system was leaking and had residue inside the container.There was no reported adverse event.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10721849
• MDR Text Key: 212678686
• Report Number: 3012307300-2020-10548
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1