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

Model Number HL-90

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the device leaked and beeped when switched on.There was unknown patient involvement and unknown patient 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 in middling condition, with wear and tear on surface.The tank cover was found to be broken.After visual inspection, the device was unpacked, the tank filled with water, and a disposable was attached.After the start button was pressed the device was fully functional, and no alarm turned on.All the alarm tests were performed, and after each test the device had recovered and working well.The only thing that was noticed was leakage after the device was running for a few minutes.As a result, the problem was only partially duplicated.A new tank cover was installed, as well as tank gasket and o-rings, and this time no leaking was noticed.A temp check was also attached, and the temp was stable and in range.A cost estimate was created in the end per the customer's request.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.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18861418
• MDR Text Key: 337205290
• Report Number: 2183161-2024-00187
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)200928
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/07/2024

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: 02/12/2024
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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