MAUDE Adverse Event Report: ST PAUL LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90); WARMER, THERMAL, INFUSION FLUID

Model Number HL-90

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that the level 1 hotline low flow system (hl-90) was tripping the line isolation in the or room.No patient injury or complications were reported in relation to this event.

Event Description

Additional information was received indicating that there was no patient involvement.The product problem was observed during testing.The unit did not alarm.

Manufacturer Narrative

H6: patient code updated to reflect code 2645.H10: device evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.The float switch was peeling, the enclosure was cracked in multiple places and marked, and both covers were cracked.The line cord was also worn.The heater did not pass the electrical test.The customer reported product problem (unit tripping line) was confirmed.The product problem occurred due to a faulty heater.There was excessive current drawn from the faulty heater.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 this reported product problem was unknown.A root cause was not established.The heater was replaced.The device subsequently passed all the functional tests.

• Brand Name: LEVEL 1 HOTLINE LOW FLOW SYSTEM (HL-90)
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10645629
• MDR Text Key: 210363091
• Report Number: 3012307300-2020-10228
• 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: 11/18/2020

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: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1