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

Model Number 6400

Device Problems Failure to Prime (1492); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  Injury  

Event Description

Spontaneous.Patient reporting both of the cadd legacy pumps (serial numbers (b)(4)) are not priming.Pt is pressing and holding the prime button, but it is not responding and the three dashes not appearing.Pt checked the lock code and it is "ii1".Advised patient to go to the hospital.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? unknown.Is the actual device available for investigation? yes.Did we replace device? yes.Did the patient have a backup device they were able to switch to? no.Was the patient able to successfully continue their therapy? no.If no, what was the patient instructed to do in able to continue their infusion? go to the hospital.Is the infusion life-sustaining? yes.What is the outcome of the event? ongoing.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD PUMP LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 12954523
• MDR Text Key: 281936266
• Report Number: MW5105873
• 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: 12/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female