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

Model Number HL-90

Device Problem Circuit Failure (1089)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.The customer reported product problem was not reproduced during testing.The investigator did not however that there was an intermittent connection between the power switch and pcb (a design issue).This may have tripped the circuit breaker that the customer mentioned.The customer reported product fault was ultimately attributed to a design issue.This was established as the root cause.The unit was determined to be beyond economical repair due its old age.No repairs were made.

Event Description

It was reported that level 1 hotline low flow system (hl-90) displayed an issue with the trip circuit breaker.No patient injury or complications were reported in relation to this event.

• 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
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11380818
• MDR Text Key: 233724613
• Report Number: 3012307300-2021-01567
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1