MAUDE Adverse Event Report: SMITH'S MEDICAL ASD, INC. PUMP CADD LEGACY; PUMP, INFUSION

Model Number 6400

Device Problems No Audible Alarm (1019); Failure to Infuse (2340)

Patient Problems Dyspnea (1816); Headache (1880); Pain (1994); Dizziness (2194)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Per patient, on monday (b)(6) /2023, she mixed a new cassette and went to work.She felt tired and out of breath but that is normal for her sometimes and she didn't know that something was going on with her infusion.When she got home around 10:40pm, she realized that her cassette was still full of medication.The pump didn't give her any alarm and the cassette was not delivering the medication.Patient mixed a new cassette and started her infusion at the same pump rate she was on prior to the interruption in treatment.Per patient, she experienced dizziness and headache, pain and she was feeling out of breath/tired for about 2 hours from starting the new cassette and she missed 2 days of work because of this.She wanted to get stabilized with her dose before returning to work again.Patient didn't have the cassette lot number to provide.Did the reported product fault occur while in use? yes.Did the product issue cause or contribute to patient or clinical injury? yes.If yes, was any medical intervention provided? no.Pumps with serial numbers (b)(4) due dates unknown are in patient¿s possession.Unknown which pump was in use at time event occurred.Iv remodulin patient.Pump return tracking information is not applicable to event as pump is not being returned or exchanged at this time.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not applicable.No additional information is available at this time.Reported to (b)(6) by: patient/caregiver.

• Brand Name: PUMP CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITH'S MEDICAL ASD, INC.
• MDR Report Key: 16305558
• MDR Text Key: 308974452
• Report Number: MW5114713
• Device Sequence Number: 3
• Product Code: LHI
• 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: 02/01/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Age: 44 YR
• Patient Sex: Female