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); Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the water level alarm would not shut off.Patient involvement unknown.

Manufacturer Narrative

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.

Manufacturer Narrative

Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(4).One device was received.Per visual inspection, discolored pole clamp, quick connect corroded, scratches in the paint on the enclosure, global display label had dents in it.Per functional testing, the water level alarm (float switch) was alarming.The complaint was confirmed.The root cause was a malfunctioning float switch from spliced connector wires by the user.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 float switch, printed circuit board (pcb) (due to service error), quick connect, global display label.Performed preventative maintenance (pm), changed o-rings, reservoir gasket and calibrated.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: 18059255
• MDR Text Key: 327210329
• Report Number: 3012307300-2023-10196
• 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: 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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: 10/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1