MAUDE Adverse Event Report: OAKDALE HOTLINE 3 BLOOD FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number	L-370
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a during a craniectomy,ventriculostomy case the crna noticed that the sterile water in the fluid warmer container looked blood tinged, the result of some backed up blood in the iv tubing.The fluid warmer device and tubing were disconnected from the patient and examined.It appeared that the fluid warmer tubing was defective and allowed mixture of the sterile water from the warmer with the patient's iv fluid.This was confirmed by connecting a new set to the fluid warmer and not encountering the same issue.No patient harm or injury was reported.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Photos received: two photos were included in agile complaint attachments for evaluation; it was observed a fluid warmer with sterile water container and one photo of the defective fluid warmer tubing.Received sample: one (1) sample was received in used conditions without original package.Visual inspection results from visual inspection: no anomalies were detected per psychically evaluation; however, leak test could not be performed since blood was observed through the tube.Root cause cannot be determined since the sample was not received in conditions to perform a thorough investigation.No corrective actions are required since the complaint was not confirmed.No lot number was provided; therefore, dhr (device history review) could not be performed.

• Brand Name: HOTLINE 3 BLOOD FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13518700
• Report Number: 3012307300-2022-03283
• Device Sequence Number: 14764501
• Product Code: LGZ
• UDI-Device Identifier: 10695085002819
• UDI-Public: 10695085002819
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: L-370
• Device Catalogue Number: L-370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown