MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL RAPID INFUSER (TUBING); DEVICE WARMING, BLOOD AND PLASMA

Lot Number 3179924

Device Problems Insufficient Flow or Under Infusion (2182); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

Event Type  Injury  

Event Description

Smiths medical level 1 normothermic iv fluid infuser had kinks in the tubing (caused by the clamps) which led to the infuser not infusing rapidly.Staff had to switch to a manual process.All other products were observed to have the same problem (kink in tubing due to clamp).Fda safety report id # (b)(4).

• Brand Name: SMITHS MEDICAL RAPID INFUSER (TUBING)
• Type of Device: DEVICE WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8970858
• MDR Text Key: 157324248
• Report Number: MW5089610
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Lot Number: 3179924
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR