MAUDE Adverse Event Report: NULL LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Device Alarm System (1012); Fire (1245); Overheating of Device (1437)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported the device heats immediately to overtemperature alarm.When the device was opened, traces of fire were found in the lower part of the mainboard.Device came from the device pool and the issue was detected by the technican during maintenance.No patient involvement or injury has been reported.

Manufacturer Narrative

Device evaluation 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.Udi#: unknown.Operator of the device: unknown.

Manufacturer Narrative

Device available for evaluation, device evaluated by manufacturer, event methods, evaluation, and conclusion codes: updated.The device was unpacked and after a visual inspection the tank was filled with water and a disposable was attached.The device was turned on and it had start working, but in a short time the over temp had occurred.After the front cover was removed it was noticed that the printed circuit board (pcb) was damaged, burned.This means that a short circuit did happen confirming the reported complaint.A root cause was determined to be damage to the printed circuit board (pcb) produced by an electrical short.A device history record (dhr) review found the reported device passed all functional tests during assembly and the printed circuit board (pcb) board fully operated to specification.The printed circuit board (pcb) was replaced, and the device was working, and no other error had occurred.A long-term test about 3 hours? time was performed in which the device was fully functional.Other repairs include replacing o-rings, tank gasket and tank cover.A functional test was performed, temp was stable and in the range all time., corrected data: corrected d5: operator of the device.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section G): NULL
• MDR Report Key: 16162567
• MDR Text Key: 307452579
• Report Number: 3012307300-2023-00478
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• 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-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1