MAUDE Adverse Event Report:; PUMP, INFUSION

Model Number 6500

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Cyanosis (1798); Skin Discoloration (2074); Malaise (2359)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Customer facility phone number: (b)(6).

Event Description

Information was received indicating that a smiths medical pump was under delivering medical fluid.The patient's face turned blue and the patient felt sick.No additional medical treatment was needed and the issue was resolved.There were no other reported adverse events.

• Type of Device: PUMP, INFUSION
• MDR Report Key: 11455561
• MDR Text Key: 240756750
• Report Number: 3012307300-2021-01857
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR