MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One level 1 hotline low flow systems - hl-90 was returned for analysis.The device had a broken or cracked front cover and tank cover.Damaged and taped line cord, worn enclosure and outdated printed circuit board and power switch.The device was visually inspected, and the tank was filled with water.The water tank was found to be cracked.No action was taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

Event Description

Information was received indicating that the level 1 hotline low flow systems - hl-90 had an unspecified failure that was observed during the restocking process.There were no adverse events reported.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 3350 granada avenure north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneaplois, mn ; 3833310
• MDR Report Key: 10063927
• MDR Text Key: 191235573
• Report Number: 3012307300-2020-04137
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1