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

Model Number HL-390

Device Problem Defective Alarm (1014)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.Investigation summary: the affected device was returned for evaluation.The pcb was damaged with broken lcd and led's, the float switch was stained, the pump was noisy, and the heater was rusty.After visual inspection, the water tank was filled with water, the disposable temp check was attached, the line cord was plugged in, and the power switch was turned on.The customer's indicated failure could not be replicated as the device didn't alarm due to the pcb being too damaged.As a result, no root cause could be determined.The float switch, pump, pcb, and heater were replaced.Calibration and preventative maintenance were performed, and all alarms were tested and performed as they should.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.

Event Description

It was reported that the device was alarming.There was unknown patient involvement and no patient harm/adverse event reported.

• Brand Name: LEVEL 1 LOW FLOW - HOTLINE FLUID AND BLOOD 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: 18717444
• MDR Text Key: 335722061
• Report Number: 2183161-2024-00140
• Device Sequence Number: 1
• Product Code: LGZ
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• 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