MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problems Device Alarm System (1012); Low Audible Alarm (1016); No Display/Image (1183)

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 screen on the front did not work, and it had low pitch alarms.Patient involvement unknown.

Event Description

Additional information received via email.The event occurred during testing.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

A1, a2 thru a6, b5, b6, b7, d9.Device available for evaluation, d9.Date returned to mfg: 23-jan-2024, h3, and h6.Evaluation codes: updated investigation summary: the affected device was received for evaluation.Visual inspection confirmed the device was very dirty, the front cover was faded and scratched, the reflux plug was missing, the pole clamp was discolored and damaged, the line cord was faded and worn, the quick connect was corroded, the water tank was stained, the water tank cover was cracked, and the pcb and power switch were outdated.The tank was then filled with water, the temp check disposable was attached, the line cord was plugged in, and the power was turned on.The customer's indicated failure was confirmed as the lcd did not work and the alarms were very faint.The root cause was determined to be the board.As a result, no action was taken due to the condition of the device.It was deemed beyond economical repair and will be scrapped.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.D4.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18538715
• MDR Text Key: 333322816
• Report Number: 2183161-2024-00070
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: (01)50695085820909(21)20060308(11)060221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2006
• 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