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

Model Number HL-90

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Break (1069); Display or Visual Feedback Problem (1184); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d4: udi number 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 fluid warmer was received at the customers biomed shop with a cracked case.When performing a functionality check for additional damage, the "general" alarm test was failing.A green light emitting diode (led) was staying illuminated, red light emitting diodes (leds) were not illuminating, there was no audible alarm, and the water circulation stopped.Patient involvement unknown.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received with front cover broken on upper right side, printed circuit board (pcb) had all but one (1) led broken off, pole clamp had deep scratches in it, quick connect corroded, water tank cover was scratched, elbow on pump had a nonconforming clamp on it.The front cover was broken, there was no green led only 1 red led.Passed functionality test and water did not stop circulating.Complaint was confirmed.A root cause was broken enclosure and pcb board components from impact damage.A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service in the previous 12 months and there was no indication that the complaint was related to a previous service of the device.Replaced pcb and front cover, quick connect fitting, water tank cover, pole clamp, rusty dual thermistor and microswitch.Performed preventative maintenance (pm) and calibration.Device passed all functional and delivery tests.

• 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: 16816689
• MDR Text Key: 314024928
• Report Number: 3012307300-2023-04581
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 04/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1