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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

Information was received indicating that the patient's blood was found in the reservoir of a smiths medical level 1® hotline® blood and fluid warmer.There were no reported adverse effects.

Event Description

Additional information was received that incident did occur while in use with a patient and that no patient injury resulted.It was reported that the surgery manager and anesthesia technician stated device was filled with saline, rather than the recommended 9:1 parts distilled water and hydrogen peroxide.

• 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 n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9368723
• MDR Text Key: 167779855
• Report Number: 3012307300-2019-06796
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: No
• 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