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

Catalog Number HL-90

Device Problems Device Alarm System (1012); False Negative Result (1225)

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

Event Type  malfunction  

Event Description

It was reported that the disposable set alarm kept going off.Patient involvement unknown.

Manufacturer Narrative

Other, other text: b3: 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.The event occurred during biomedical engineering's acceptance testing prior to the device being put into service in the facility.No patient involvement.

Manufacturer Narrative

Email is:(b)(6).H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection noted a missing lever on the micro switch.Functional testing found the disposable alarm went off continuously; confirming the customer complaint.Root cause was attributed to the missing lever on the micro switch; which triggers the device to circulate the water.The broken and missing microswitch lever was attributed to wear from usage.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 micro switch and o-rings.Performed preventative maintenance.Device passed functional testing after the completed repairs.

• 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: 17785371
• MDR Text Key: 323877198
• Report Number: 3012307300-2023-09153
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1