MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-390

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Component Missing (2306)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluation; one device was returned for investigation.Visual inspection found damaged printed circuit board (pcb) has led's and lcd parts broken off.Device also has a cracked tank cover.The complaint was confirmed.Root cause of the reported issue was dropping the device.The pcb and tank cover were replaced.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.

Event Description

It was reported that during testing of preventive maintenance, the alarm was not alarming.Opened the front cover and they did not see any of the lights.They do not know if it was dropped and some screws were missing.There was no patient involvement and no harm/adverse event reported.Event occurred at the hospital.Outcome of the event is ongoing as the device needs repair.Repair center stated that they think the unit was dropped but staff did not report that to them.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER, 390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• 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: 19100871
• MDR Text Key: 340273805
• Report Number: 3012307300-2024-02563
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: (01)10695085002796(11)230223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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