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

Model Number 6400

Device Problems Device Alarm System (1012); Leak/Splash (1354); Output Problem (3005)

Patient Problems Diarrhea (1811); Heart Failure/Congestive Heart Failure (4446)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Patient reports an emergency room visit where she had to be admitted for 24 hours due to heart failure.Patient stated that one of her remodulin vials(patient discarded vial) had a bad stopper and the medication would leak out as she would fill her syringe.Patient feels as though the medication lost its potency due to the bad stopper so she wasn't getting her full dose.When patient mixed a cassette using new vial of remodulin patient was unable to tolerate the medication and had to reduce her dose.Patient was then unable to increase back to her previous dose due to diarrhea.Patient had md appointment today.Patient thinks the md would like her to be able to increase to previous dose but she can't due to diarrhea.Patient reports pump sn (b)(4) alarms frequently so she has only been using one pump, author advised we would set up order for replacement pump for early am delivery.No additional information.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14775815
• MDR Text Key: 294617616
• Report Number: MW5110410
• Device Sequence Number: 1
• 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: 06/16/2022
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female