MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number H-1200

Device Problems Inaccurate Delivery (2339); Improper Flow or Infusion (2954); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Rapid infuser not working properly, would not empty bags completely, was rapid infusing blood - 1/2 of blood volume would go in quickly then other half would drip in slowly - as if there was not enough pressure on the bags?.

• Brand Name: LEVEL 1 H-1200 FAST FLOW FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12532022
• MDR Text Key: 273332178
• Report Number: 12532022
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H-1200
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2021
• Date Report to Manufacturer: 09/27/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1