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 Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

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 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 heating tube installation confirmed that the alarm wasn't working.There was unknown patient involvement and unknown patient harm/adverse event reported.

Manufacturer Narrative

Evaluation codes: updated.One device was received.Per visual inspection, cracks were observed in the water tank cover.Per functional testing, the alarm for no disposable tube activates even if the heating tube is attached.The complaint was confirmed.The root cause was a defective micro switch.It was unknown what caused it to become defective.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.It was recommended that the micro switch be replaced, and at the customer's request, the product was returned without repair.

• 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: 18751537
• MDR Text Key: 335901294
• Report Number: 3012307300-2024-00927
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 01/23/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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