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

Model Number HL-390

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the fluid warmer had broken lcd.The product problem was discovered during preventative maintenance.The device was fully operational with damage to only the display.There was no patient involvement.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed that the enclosure was heavily stained and marked, both covers were cracked and marked, the line cord was worn, and the pole clamp handle was broken.The investigator subsequently filled the tank with water, attached the temperature check, plugged in the line cord, and turned on the power switch.The customer reported product problem (broken lcd) was confirmed during testing.The product problem occurred because of a damaged pcb board.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 damaged pcb and aforementioned components were replaced.Preventative maintenance was then performed.The device subsequently passed functional testing.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10026289
• MDR Text Key: 189915693
• Report Number: 3012307300-2020-03652
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HL-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1