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

Catalog Number CON-HL-90

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.

Event Description

It was reported that the numbers are jumping on the display.There was no additional information provided.

Manufacturer Narrative

Other, other text: additional event information received indicating that it is unknown if a patient was involved (updated b5, h6).Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the pump was noisy.Functional testing cannot duplicate the customer complaint.The device was run for several hours and the numbers on the display stayed the same after the temperature stabilized.Device passed all functional testing, unable to replicate the reported issue.No problem found.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.

Event Description

Additional information was received which included the event date and that it is unknown if a patient was involved.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13965322
• MDR Text Key: 288322084
• Report Number: 3012307300-2022-05612
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1