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

Model Number HL-390

Device Problem Contamination (1120)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported the device had fluid contamination.Reporter stated there was no patient involvement.

• Brand Name: LEVEL 1 HOTLINE 390 FLUID WARMING DEVICE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12981023
• MDR Text Key: 282104495
• Report Number: 3012307300-2021-12631
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1