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); Overheating of Device (1437); Pumping Stopped (1503)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event and d5.Operator of device 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 device stops running after five (5) minutes and reads over temperature alarm.Patient involvement unknown.

Manufacturer Narrative

D9: date returned to mfg.: 1/10/2024.D10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Per visual inspection, the enclosure has some tape and other adhesive residue on portions of it.The top socket was leaking fluid.There is evidence of fluid ingression on the printed circuit board (pcb).The air detector failed the pin gauge test, the plunger does not descend fully allowing the pin gauge to pass freely underneath (the pin gauge should go no further than halfway under the plunger).A portion of the membrane switch ribbon shows signs of corrosion on the traces, an old-style clear float switch is cracked.The right door mount is damaged.Mount block assembly is worn.Per functional testing, the device ran for about two and a half minutes before the over temperature alarm activated.The complaint was confirmed.The root cause was fluid ingression on the pcb due to a leak from the o-ring.It was unknown what caused the condition.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/tightened the screws and replaced the spring.Replaced the mount block assembly and both door mounts on the air detector.Replaced the membrane switch, pcb, o-rings, float switch 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: 18530499
• MDR Text Key: 333509535
• Report Number: 2183161-2024-00063
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• 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: 01/17/2024
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2011
• 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