MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number 8002950

Device Problems Device Alarm System (1012); No Flow (2991)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5: operator of device are unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.Visual inspection found scuff marks on the top left corners of the enclosure.The air detector bracket was bent causing the air detector to not be seated fully against the tower.There are a couple dents on the back panel as well.Functional testing found the device does not go into "operations mode", the green light lit on the display.The bent air detector bracket caused the bottom 3/4 of the air detector to protrude from the device.This in turn caused the gas/vent filter to not engage the filter holder micro switch fully, resulting in an interlock (disposable) alarm.That is also why there is no water flow, all interlocks were not satisfied for the device to run as intended.The top socket assembly (#2) works as intended.The alarm complaint was confirmed.The connection complaint was not duplicated.Root cause was attributed to the bent air detector bracket.What caused the physical damage to the component was not established.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.The air detector bracket was replaced.The o-rings and fan guard were replaced for preventative maintenance.Device passed functional testing after the completed repairs.

Event Description

It was reported that the device was "constantly alarming water isn't flowing".Also reported was the "latch top is loose and not engaging".There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18691415
• MDR Text Key: 335309952
• Report Number: 3012307300-2024-00747
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1