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

Model Number HL-90

Device Problems Defective Component (2292); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the switch that detects the tubing was broken and would not run.Patient involvement unknown.

Manufacturer Narrative

Other, other text: b3: date of event and d4: udi number 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.

Manufacturer Narrative

Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device was received.Per visual inspection, the lever from microswitch taped on the top of the unit.No other physical damage observed.Observed the microswitch was missing the lever.The complaint was confirmed.A possible cause was the customer forced temperature check into microswitch.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 microswitch.Changed o-rings and reservoir gasket.Performed preventative maintenance (pm) and calibrated the unit.The device passed all functional and delivery tests.

• 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: 17686458
• MDR Text Key: 322831776
• Report Number: 3012307300-2023-08670
• 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: 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
• Report Date: 01/30/2024

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 Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1