MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-10

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

It was reported that none of the alarms worked on a level 1® hotline® blood and fluid warmer.The customer states that this was an out of the box failure.After setting up the device and letting it run for a half hour, none of the alarms worked after performing all alarm tests.There was no patient involvement.

Manufacturer Narrative

A level 1® hotline® blood and fluid warmer was returned in new condition.Pressed alarm test button and no visual or audible alarm was initiated.Removed front cover for further inspection.Found ribbon cable for alarm test membrane switch disconnected from circuit board input.Based on the evidence, the complaint was confirmed.The root cause for this issue is related to a manufacturing process.

• Brand Name: LEVEL 1® HOTLINE® BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 1265 gray fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathane lane north; plymouth, MN 55442 ; 7633833310
• MDR Report Key: 7005801
• MDR Text Key: 91539558
• Report Number: 3012307300-2017-02385
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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