MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Failure to Sense (1559); Temperature Problem (3022); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event and d4: udi section 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 the user cannot adjust the temperature and the unit was noisy.This was reported as an "out of the box failure".No patient or clinical injury reported.

Manufacturer Narrative

Other, other text: additional information is provided in h.2., h.3., and h.6.Device evaluation: one device was received for investigation.A visual inspection found a cracked tank cover, liquid crystal leakage in the lcd, and damaged pots on the pcb.A review of the event history log found no applicable history.During the functional testing, it was found that the temperature could not be adjusted on the pcb and during circulation the device was loud confirming the customer complaint.The cause of the issue was found to be that the pot on the pcb used to adjust the temperature was damaged and the faulty pump was noisy when running.No action was taken due to the condition of the device.It was deemed beyond economical repair and will be scrapped.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18231842
• MDR Text Key: 329286663
• Report Number: 3012307300-2023-10809
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1