MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Catalog Number H-1000

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 12/08/2015

Event Type  Injury  

Event Description

The rapid infuser would not run at the correct rate.The patient was in need of blood and needed that blood rapidly.Bags pressurized but blood continued to "trickle" in.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada avenue north suite 100; oakdale MN 55128
• MDR Report Key: 5466188
• MDR Text Key: 39218661
• Report Number: 5466188
• Device Sequence Number: 1
• Product Code: BSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: H-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 76 YR
• Patient Weight: 48