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

Catalog Number 8002950

Device Problems Insufficient Heating (1287); Under-Sensing (1661); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.H3: other; device not returned to manufacturer.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

It was reported that the was unit not warming up.Patient involvement unknown.

Manufacturer Narrative

D9: date returned to mfg.: 1/17/2024.H3 and h6.Evaluation codes: updated.One device was received.Per visual inspection, there were some superficial scratches in the line cord, delamination of the membrane switch ribbon and the beginning of corrosion are also present on the traces of the ribbon.There is some type of foreign object (ending up being gauze) stuck in the top socket obstructing the water flow completely, this is why the device was not heating.Per functional testing, the device did not heat up properly.The complaint was confirmed.The root cause was due to an obstruction in the top socket preventing water circulation, this triggered the device to not activate the heaters.After the obstruction was removed the device worked as intended.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 membrane switch, o-rings, and fan guard for preventative maintenance.The device passed all functional and delivery tests.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18505617
• MDR Text Key: 333316415
• Report Number: 2183161-2024-00034
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: (01)50695085829506(11)200324
• 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,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2020
• 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