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

Model Number HL-90

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

Date of event and operator of device are 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.

Event Description

It was reported that "setting off the line insolation monitor." patient involvement is unknown.

Manufacturer Narrative

H3 and h6.Evaluation codes: updated.One device was received.Per visual inspection, cracked enclosure, stained water tank, water tank cover leak from reservoir, faded line cord.Outdated drain fitting, printed circuit board (pcb), and power switch.Functional testing could not duplicate or confirm the complaint.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was 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: 18763749
• MDR Text Key: 336618730
• Report Number: 3012307300-2024-00958
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Date Returned to Manufacturer: 02/06/2024
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2010
• 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