MAUDE Adverse Event Report: CONSIGNED 115V DOMESTIC HOTLINE; WARMER, THERMAL, INFUSION FLUID

Model Number CON-HL-90

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical pump's lcd numbers would jump up and down.There were no reported adverse events.

Manufacturer Narrative

Returned device was received cracked enclosure and tank cover.Outdated pcb, power switch, and front cover.Worn line cord.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to user interface.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CONSIGNED 115V DOMESTIC HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 10367812
• MDR Text Key: 201702792
• Report Number: 3012307300-2020-07824
• Device Sequence Number: 1
• Product Code: LGZ
• 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: 09/28/2020

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: Health Professional
• Device Model Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1