MAUDE Adverse Event Report: OAKDALE LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 8002950

Device Problems Overheating of Device (1437); Temperature Problem (3022); Key or Button Unresponsive/not Working (4063)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that upon assembly and performance testing it was found that the power off button was not functioning.The device would over temp during testing.No patient involvement was reported.

Manufacturer Narrative

Other, 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

Additional information received 5-july-2023 via email: issue was discovered prior to the patient use and no patient or clinical injury.There is no medical intervention required and the outcome of event is ongoing.The event occurred on 12- june-2023.

Manufacturer Narrative

Evaluation codes: updated device evaluation: one device was returned for investigation.Device failed flow rate test.Visual inspection found the device was missing the tank fill plug, had a cracked return tube, and the power off button does not work.The low flow rate can cause the device to "over temp" over time.It did not "over temp" during the investigation.The customer complaint was confirmed.Root cause was attributed to the power off button not working due to a broken membrane switch."over temp" caused by low flow rate due to the cracked return tube.What caused the damage could not be established.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.No actions taken at this time.Investigation only and device will be repaired when needed.Device will be sent to loaner pool.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17221755
• MDR Text Key: 318070621
• Report Number: 3012307300-2023-06833
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8002950
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1