MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Spontaneous call from pt who reported that the other day, the pump alarmed for blockage.She stated that she could not find any kinks in the tubing so she decided to replace it.While replacing the tubing, the pump alarmed that cartridge needed to be changed she accidentally spilled some of her medication while she was replacing the cartridge.Lot numbers for the tubing and cartridge are unknown.Pt did not experience any clinical injuries during this event.Unknown if her doctor is aware.Did the reported product fault occur while in use with a patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available to be returned for investigation? yes; did we replace device? no; did the patient have backup device they were able to switch to? yes; but patient did not need to use it; if yes, was the patient able to successfully continue their infusion? yes; what is outcome? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11607817
• MDR Text Key: 243750157
• Report Number: MW5100506
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2021
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR