MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE; SET, I.V. FLUID TRANSFER

Device Problems Failure to Infuse (2340); Defective Device (2588)

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

Event Type  Injury  

Event Description

A patient presented to emergency department from outpatient setting by ems.The patient was experiencing remodulin infusion failure.The patient uses premade remodulin cadd cassettes from their specialty pharmacy.They last changed their cassette at 4:00 pm the previous day.The following morning they noticed a pump error indicating drug is not infusing and called ems.Patient off remodulin for -90 minutes.Upon investigation in the ed by the nurse and pharmacist, the infusion failure seemed to have been related to a problem with the home cadd cassette (the home remodulin cadd cassette prompted error with a functioning hospital cadd legacy pump).If the cadd cassette is dysfunctional the cadd legacy pump will display an error of "no disposable alarm" on cadd pump and the infusion will not work.Remodulin was restarted using a hospital supplied remodulin cadd cassette and infused fine via the hickman catheter with the patient's home cadd legacy pump.All supplies used at the hospital functioned properly in this scenario.This was a faulty home device in the cadd cassette.Patient stable, no harm observed.Remodulin therapy resumed within 5 minutes of presenting to the ed and identifying the problem.The patient's specialty pharmacy was contacted to inform them of this event.A plan was developed for the specialty pharmacy to reach out to the patient that day to coordinate new shipment of remodulin.The specialty pharmacy will ship the patient a box to return the faulty cassette to the specialty pharmacy.The specialty pharmacy will assess the cassette, report to the fda, and send to the manufacturer for investigation.The patient has back up supplies at home to prepare a cassette in the event of cadd cassette pump failure.This appears to be a rare occurrence in the outpatient setting and our hospital has no reports of this happening for inpatients receiving these therapies at our facility to date.The outpatient specialty pharmacy caring for this patient was aware of the problem with faulty cadd cassettes.The manufacturer of the cadd cassette (smiths medical) is aware of this problem and are actively investigating per the specialty pharmacy.The problem has not been tied to a specific lot of the products and appears to be occurring sporadically at this time.(b)(6).

• Brand Name: CADD CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12934863
• MDR Text Key: 281906784
• Report Number: MW5105826
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2021
• Patient Sequence Number: 1
• Treatment: HICKMAN CATHETER; INFUSION PUMP
• Patient Outcome(s): Hospitalization