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

Model Number HL-90

Device Problems Defective Alarm (1014); No Audible Alarm (1019); No Display/Image (1183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2023

Event Type  malfunction  

Event Description

It was reported that the temperature display was not working.The device was also failing in the high temperature alarm testing.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

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 required.

Manufacturer Narrative

One device was received in good condition apart from a broken reflux plug.Functional test was performed, and the reported problem was replicated as device had faulty printed wiring assembly (pwa) that only shows value "1".It was also the reason why the device was failing high temperature alarm test.A root cause was not able to be determined.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.The printed wiring assembly (pwa), reflux plug, and water tank enclosure was replaced.After the device was repaired it passed functional tests.

Manufacturer Narrative

Health effects codes, updated.

Event Description

Additional information received via email.The event was observed on (b)(6)2023 during testing.No patient involvement.

• 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: 16629911
• MDR Text Key: 312155881
• Report Number: 3012307300-2023-03104
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 03/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1