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

Model Number HL-90

Device Problems Display or Visual Feedback Problem (1184); Low Readings (2460)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event and d5.Operator of device: 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.A product sample was received and is awaiting evaluation, investigation including root cause analysis is in progress.

Event Description

It was reported that the product heated up, but the temperature display on the main unit showed 10 to 11 degrees.There was no patient involvement.

Manufacturer Narrative

One device was received for investigation.The device was functionally tested.Although it heated up, it was confirmed that the temperature display on the main body lcd did not display the correct value and the led did not light up.Failure of the main pc board inside the main unit is the root cause of the problem.The main pcboard and ac power switch need replacement.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.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND 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: 18699873
• MDR Text Key: 335390723
• Report Number: 3012307300-2024-00776
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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-90
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2014
• 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