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

Catalog Number CON-HL-90

Device Problems Overheating of Device (1437); Failure to Pump (1502)

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

Event Type  malfunction  

Manufacturer Narrative

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 required.

Event Description

It was reported that the device was not pumping water and was overheating.Patient involvement is unknown.

Event Description

Additional information received via email and attached to complaint object: the issue was found during a routine preventative maintenance (pm).No patient was involved.

Manufacturer Narrative

Other text: d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device received with a lot of labels on it.Visual inspection noted the quick drain connect was corroded, water tank cover had multiple cracks where the screws were put in, plate clip had a nick in it, front cover had multiple scratches, pole clamp had deep gouges in it, water tank was contaminated.When performing the functional tests, the pump did not turn on.The complaint was confirmed.The root cause was due to an inoperative water pump and no longer recirculating water.It was unknown what caused the pump to fail.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced the pump, quick connect, water tank cover, plate clip, pole clamp and front cover.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: 16877535
• MDR Text Key: 314931383
• Report Number: 3012307300-2023-05162
• 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,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/08/2023; 08/24/2023
• Supplement Dates FDA Received: 05/26/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1