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

Model Number HL-90

Device Problems Device Alarm System (1012); Failure to Deliver (2338); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event is 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 as soon the device was turned on the over temperature alarm turns on and the unit stops circulating the liquid.Patient involvement unknown.

Manufacturer Narrative

Evaluation codes: updated device evaluation: one device received for investigation.Visual inspection noted: device received very dirty, power switch is damaged and connected to the old style printed circuit board (pcb), water tank is stained with rust, corroded quick connect, pole clamp is discolored, microswitch was stuck onto plate clip, front cover and enclosure have multiple deep scratches.Functional testing found the device started alarming immediately.Root cause was attributed to a faulty pump.Failed water pump no longer recirculating water due to wear of age.Device manufactured in 2005 and first time in for service.The product's history records were reviewed and there were no non-conformance's nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped or returned to the customer.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND 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: 17430997
• MDR Text Key: 320157333
• Report Number: 3012307300-2023-07652
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1