MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evlaution in progress.

Event Description

It was reported that during pre-test, the operator discovered that the device over temp led was missing/broken.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 a damaged pcb and a broken lcd.The customer reported product problem (over temp led missing/broken) was confirmed during the investigation.The product problem occurred because of some force or impact to the front of the hot line device.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 investigator concluded that the aforementioned impact/damage was caused by the customer.The pcb and lcd were replaced in order to repair the device.Preventative maintenance was subsequently performed.The device then passed all the functional tests.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-390
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9715179
• MDR Text Key: 179715493
• Report Number: 3012307300-2020-01110
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

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: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/15/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1