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 Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evlaution in progress.

Event Description

It was reported the device lights on the inside board were not working.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

B5, h6: additional information.One fluid warmer was returned for evaluation.Visual insepction of the device found it to have a dirty enclosure, stained and missing all of its rubber feet's.Pole clamp is dirty and damaged, as well as a line cord noted to be old and worn.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.Device underwent functional testing by filling tank with water, and powering it on.The reported customer complaint has been confirmed as a result of damage to the pcb board and the led lights.The problem source has been determined to be unknown.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

Event Description

Information was received that incident occurred during preventive maintenance; no patient involvement.

• 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: 9715242
• MDR Text Key: 179717821
• Report Number: 3012307300-2020-01118
• 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: 04/21/2020

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: 01/28/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/16/2020
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1