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 Type  malfunction  

Event Description

It was reported the device had internal fluid damage.No adverse effects reported.

Manufacturer Narrative

Device evaluation: the device was returned for evaluation.The device was examined; this showed wear at the tank enclosure and the block assembly (where warming set is attached).The device was given functional testing; this showed the recirculating fluid had debris in it.The investigation was determined caused due to either a leak within a fluid warming set or the user did not use clean water when filling.

• 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: 13028312
• MDR Text Key: 282486286
• Report Number: 3012307300-2021-12702
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1