MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-390

Device Problems Device Alarm System (1012); Fracture (1260); Defective Component (2292)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that the device had a damaged "lec, temperature alarm.The fault was found during testing.There was no issue related to physical damage or mishandle abuse and there was no delay of therapy.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Investigation summary: the affected device was returned for evaluation.It had liquid crystal leakage in lcd, a faulty pump, corroded drain fitting, cracked tank cover, rusty heater, and the screw stuck in the pole clamp.Started with a visual inspection then filled tank with water, attached temp check, plugged in line cord, and turned on the power switch.Performed functional tests using procedure sr-hl-390.The lcd had liquid crystal leakage and the over temp alarm was out of calibration, confirming both of the customer's indicated failure modes.Probable cause of the damaged lcd is impact or force to the lcd.A faulty pcb or physical damage may have caused the over temp alarm to fail.As a result, the pcb was replaced.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.D4.Unique identifier (udi) #:(b)(4).

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 18983714
• MDR Text Key: 338696407
• Report Number: 3012307300-2024-01683
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(21)22013720(11)190923
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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