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

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that in a survey the following question was asked: "does the level 1 fluid warming device set up allow for rapid deployment and ease of use in an emergency situation?" response was: "they don't set up personally but know that techs struggle sometimes".No further details were provided.No patient death or serious injury was reported.

Manufacturer Narrative

Event date is unknown.No catalog, model, lot or serial numbers were communicated.Device expiration date and device manufacturing date not available.Device evaluation including root cause analysis is in progress.No product was returned for investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.Additional information: the complaint information was provided from a 3rd party company who conducted a general post-market clinical follow-up (pmcf) activity on our company's behalf.Post-market clinical follow-up for this product family is required to comply with eu mdr requirements.This general pmcf activity consisted of interviewing clinicians anonymously about safety and performance of the level 1 hotline and fast flow temperature management systems at the asa (american society of anesthesiologists) anesthesiology conference from 21-october-2022 through 25-october-2022.Devices within the scope of this activity included intravascular devices only, not irrigation products.

Manufacturer Narrative

H10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: LEVEL 1 FLUID WARMER
• Type of Device: 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: 15807107
• MDR Text Key: 307572479
• Report Number: 3012307300-2022-27248
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1