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

Model Number HL-390

Device Problems Crack (1135); Fluid/Blood Leak (1250); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed that the float switch was defective.The pump was vibrating heavily and making noise.The lcd and the pcb were damaged.There was a crack on the enclosure by the drain fitting.The water tank was leaking, and both the covers were cracked and marked.The micro switch was broken, and the line cord was worn.The investigator subsequently filled the tank with water, plugged in the line cord, and turned on the power switch.The customer reported product problem (leaking around the screws) was confirmed during testing.In addition, the investigator also noticed that the heater failed the electrical tests.The product problem occurred because the user over-tightened the screws in the tank cover.The user caused the cracks.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 product problem was attributed to a user issue.The aforementioned components were replaced.Preventative maintenance was then performed.The device subsequently passed functional testing.

Event Description

It was reported that level 1 hotline low flow system (hl-390) was leaking around the screws.The unit did not produce any alarms.The product problem was observed during preventative maintenance.There was no patient involvement.

Manufacturer Narrative

One level 1 hotline low flow system was returned for analysis.Upon inspection of the unit, the float switch was noted to be defective, pump vibrated heavily making noise, lcd was cracked, enclosure was noted to be cracked and both covers were cracked.The tank was filled with water, temp check was attached, line cord was plugged in and the unit was then turned on; confirming complaint of leaking around the screws.Based on the evidence, the complaint was confirmed.The root cause was found due to user interface as the water tank cover was observed to be cracked from over tightening of the screws.

• 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: 10189518
• MDR Text Key: 196251462
• Report Number: 3012307300-2020-06199
• 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: 07/13/2020

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-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1