MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

Event date is unknown.No information has been provided to date.A product sample was received and is awaiting evaluation and 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 during the preventative maintenance (pm) it was displaying a random number on the screen.No patient involvement reported.

Manufacturer Narrative

Other text: h3 and h6 - health impact and evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection noted: the device showed wear and tear on the line cord, drain fitting, and pole clamp assembly.Damaged mircoswitch and faulty printed circuit board (pcb) were also found.Functional testing confirmed the complaint.Root cause was attributed to a faulty pcb.What caused the faulty pcb could not be determined.Product was beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history report (dhr) review was not required.Service history review identified this device has not been in for service previously.Replaced pcb, mircoswitch, drain fitting, tank cover, line cord, and pole clamp.Performed preventative maintenance (pm).Device passed all functional testing after the completed repairs.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; main storeroom; minneapolis, MN 55442
• MDR Report Key: 15381798
• MDR Text Key: 305458602
• Report Number: 3012307300-2022-18213
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HL-390
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1