MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW - IRRIGATION FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number	H-1100-ES-115V
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device continuously alarmed for the disposables.After trying different sets, the alarm was manually engaged but would not clear.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.D5.Other operator of device: operator of device is unknown.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.
Additional Manufacturer Narrative
The following fields were updated with corrections: d4.Unique identifier (udi) #: (b)(4).H4.Device mfg date: 07-oct-2013.Investigation summary: the affected device was received for evaluation.The tower was received without the power base/pole or ram's horn.The tower has a back panel on it from a different device, there is a different serial number written on the inside of the back panel, and the ground wire was not connected to the device either.Upon start up the disposables alarm activated.The top socket thermistor was not seated correctly in top socket which gave a false temperature reading on the lcd as well as the temp-check.After seating the top socket thermistor correctly, the temperature stabilized within calibration tolerances of 41.7° ± 0.1°c.Air pressure was measured at 5.9 psi, which is out of tolerance, it should read 5.6 psi +0.0/-0.2 psi.The air regulator was found to be missing the set screw used to adjust the air pressure.The drain valve was corroded.After visual inspection, the device was filled with fluid, a temp-check and f-30 gas/vent test filter were installed, and functional testing was performed.The customer's indicated failure was confirmed, as the disposable alarm activated on startup.The root cause was found to be the microswitch.The filter block microswitch was working intermittently, and after depressing it manually, the device ran as intended.As a result, the filter block assembly was replaced, along with the air regulator, fan guard, drain valve, and o-rings.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: LEVEL 1 FAST FLOW - IRRIGATION FLUID WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18703006
• Report Number: 2183161-2024-00133
• Device Sequence Number: 17946361
• Product Code: LGZ
• UDI-Device Identifier: 50695085828264
• UDI-Public: (01)50695085828264(11)131007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: H-1100-ES-115V
• Device Catalogue Number: H-1100
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown