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 No Display/Image (1183)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.No information has been provided to date.D4.Serial number and h4.Manufacture date are unknown; no information has been provided to date.D5.Other operator of device: operator of device is unknown.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.

Event Description

It was reported that the lcd for temperature display was broken.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.Device evaluation: one device was received.Per visual inspection, the reservoir cover was cracked, and the drain cap and rubber feet were missing.Functional testing confirmed that the liquid crystal display (lcd) of the main unit was damaged, and the temperature was not displayed.The root cause was damage to the main board.It was unknown what caused it to become damaged.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.The main pc board assembly and water tank cover were replaced.Also, attached the rubber feet and drain cap that fell off.The device passed all functional tests after repair.D4 - unique identifier (udi) #, d4 - serial number.

• 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: 18837398
• MDR Text Key: 336898032
• Report Number: 3012307300-2024-01147
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(17)190115(10)22007158
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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-90JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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