MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. LEVEL 1® H-1025 FAST FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Catalog Number 8002919

Device Problems Failure to Infuse (2340); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Event Description

Information was received indicating that during an emergent case for ruptured femoral artery, a smiths medical level 1® h-1025 fast flow fluid warmer would not deliver warm fluid and blood.The unit was changed out and the patient recovered.There were no reported adverse effects.

• Brand Name: LEVEL 1® H-1025 FAST FLOW 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.; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9598373
• MDR Text Key: 177423955
• Report Number: 3012307300-2020-00595
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8002919
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1