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

Model Number HL-90

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that the device had an unspecified problem and needed repair.There was unknown patient involvement and unknown human harm/adverse event reported.

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.Investigation summary: the affected device was received for evaluation and was found to be in good physical condition, with small amounts of wear and tear.The device was unpacked, the tank was filled with water and a disposable was attached.The start button was pressed, and the device was fully functional from the beginning, no issue was found.A long-term test, about 3 hours, was performed, and the entire time the device was fully functional and responded okay during each test.A functional test was also performed using the pm-516 thermometer.The customer's indicated failure could not be replicated; therefore, the root cause could not be determined.No further repair was necessary.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.

• Brand Name: LEVEL 1 LOW FLOW - 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18858072
• MDR Text Key: 337130666
• Report Number: 3012307300-2024-01186
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Date Manufacturer Received: 11/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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