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

Model Number HL-90

Device Problem Output Problem (3005)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the level 1 hotline low flow system was not working.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed a broken front cover. the tank cover was cracked, and the line cord was faded with bent prongs.  the unit was also equipped with an outdated pcb and power switch.The investigator subsequently filled the tank with water, attached a temperature check fixture, plugged in the line cord, and turned on the power switch.The customer reported product problem (non-functioning lcd) was confirmed during testing.The product problem occurred because of a faulty pcb.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.The unit was determined to be beyond economical repair due its old age.No repairs were made.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10019644
• MDR Text Key: 189695341
• Report Number: 3012307300-2020-03617
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 05/02/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1