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

Model Number HL-90

Device Problems Failure to Pump (1502); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the pump was humming and was not working.Issue was found in their education department.Patient involvement is unknown.No adverse event has been reported.

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection noted the device was received dirty, stained water tank, faded line card, pole clamp is loose, and the float switch is not alarming.The device has outdated printed circuit board (pcb), power switch, and quick connect.Functional testing confirmed the complaint.The pump was not working.Root cause was attributed to a faulty pump.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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: 18923545
• MDR Text Key: 337897768
• Report Number: 3012307300-2024-01438
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(11)950731
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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: 03/01/2024
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/1995
• 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