MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC FLUID WARMING LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90; WARMER, THERMAL, INFUSION FLUID

Model Number CONSIGNED 115V DOMESTIC HOTLINE

Device Problems Device Alarm System (1012); Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information received a smiths medical trippinglevel 1 hotline low flow systems - hl-90 alarmed " diposable error." this occured during testing and no patient involvement.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed wear and tear damage on the following components; enclosure, front cover, tank cover, line cord, and pole clamp. there was also a broken micro switch and stripped interlock block. the pcb and power switch on the unit were also outdated.The investigator subsequently filled the tank with water, attached a temp-check, plugged in the line cord, and turned on the power switch.The customer reported product problem (disposable error) was confirmed during testing.The product problem was attributed to a broken micro switch.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 following components were replaced: enclosure, tank cover, front cover, interlock block, micro switch, line cord, pole clamp, and reflux plug.  the investigator also upgraded the pcb, power switch, and retainer.Preventative maintenance was then performed.The device subsequently passed functional testing.

• Brand Name: FLUID WARMING LEVEL 1 HOTLINE LOW FLOW SYSTEMS - HL-90
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis, mn
• MDR Report Key: 9742954
• MDR Text Key: 180519345
• Report Number: 3012307300-2020-01416
• 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

• Date FDA Received: 02/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CONSIGNED 115V DOMESTIC HOTLINE
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1