MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEGACY CADD PUMP; PUMP, INFUSION

Device Problem No Flow (2991)

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

Event Date 05/28/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient who reports both pumps sn (b)(4) are alarming the error of no disposable, pump won't run.Patient had already tried the back-up pump and that was not working either.Discussed with patient that she could try wiping off the cassette where it attaches to the pump in case there was dust blocking the sensor.Patient decided that she would mix a new cassette as it was the day to do that anyways.Advised patient to call back if mixing a new cassette did not work.Patient did not call back.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? no; did we replace device? no; did the patient have a backup device they were able to switch to? yes.What is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: LEGACY CADD PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12672260
• MDR Text Key: 278082142
• Report Number: MW5104797
• Device Sequence Number: 2
• Product Code: FRN
• 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: 05/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 42 YR