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

Model Number HL-390

Device Problem Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One hotline® low flow system was returned for analysis in excellent condition.The tank was filled with water, temp check was attached, line cord was plugged in and the power switch was turned on; no power to the unit observed.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing as the pump failed quickly.

Event Description

Information was received indicating that upon arrival a smiths medical level 1® hotline® low flow system was not powering on.The fault was reported to occur following removal from the box and during testing.There were no reported adverse effects.

• 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 n; minneapolis,, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, mn ; 3833310
• MDR Report Key: 9914466
• MDR Text Key: 186116054
• Report Number: 3012307300-2020-02656
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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: HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability