MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 6400

Device Problems Increase in Pressure (1491); Improper or Incorrect Procedure or Method (2017)

Patient Problem Dyspnea (1816)

Event Date 11/07/2020

Event Type  Injury  

Event Description

Spontaneous call from patient to report high pressure alarm on the pump with one of the pumps.He stated that he was a physician so he knows how to troubleshoot.He reported not finding any obstructions in his line, so he switched to his backup pump and called me to request a replacement.Later the patient's daughter called and requested for a replacement to be send out for the second pump which apparently also failed with the same issue.When i was able to reach the patient, he was already at the hospital and reported that initially, the hospital staff thought that there was a problem with his hickman line not working.However, at that time, they had discovered that both pumps were fine, there was no problem with his hickman line and the source of his high pressure pump issues was actually from the extension tubing.Patient was not changing them 3 times weekly.Patient did experience difficulty breathing.Did we [mfr] replace the device? yes.Did the patient have a backup device they we're able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Did the reported product fault on while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes.Is the actual device available for investigation? yes.Reported by (b)(6) by: patient/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 10843516
• MDR Text Key: 216885619
• Report Number: MW5097881
• Device Sequence Number: 1
• 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: 11/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR