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

Model Number 6400

Device Problems Pumping Problem (3016); Incomplete or Inadequate Priming (4041)

Patient Problem Syncope/Fainting (4411)

Event Date 04/11/2023

Event Type  Injury  

Event Description

Pharmacy follow up to previously reported double pump malfunction for pump serial numbers (b)(4).Pt¿s mother reports that after the previously reported double pump malfunction that the pt did pass out and is currently admitted to the hospital and doing better now.Pt¿s mother also reports that when pt was trying to trouble shoot the double pump malfunction, the tubing wasn¿t priming; lot number for tubing is not available.Tubing was not in use when fault occurred, pt was trying to prime it.Pt¿s mother reports pt experienced some lapse in epoprostenol infusion and side effects/clinical injury due to previously reported double pump malfunction passed out.Unknown if md aware.No additional info, details, or dates available.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when alarm occurred is not applicable as no pump issue was reported.Pump return tracking information is not applicable as no pump issue was reported.Photographs were not provided.Did the reported product fault occur while in use with the patient? -pumps: yes; tubing-no.Did the product issue cause or contribute to patient or clinical injury? ¿ pumps yes: some lapse in infusion and pt passed out: tubing no.If yes, was any medical intervention provided? -yes, pt hospitalized.Is the actual product available for investigation? -pump: yes; tubing no.Did we replace product? - yes, both pumps and tubing.Did the patient have a backup product they were able to switch to? ¿ pumps no; tubing: yes.Reported to (b)(6) by: patient/caregiver.Reference report: mw5116735, mw5116736.

• Brand Name: CADD LEGACY PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL INC.
• MDR Report Key: 16762566
• MDR Text Key: 313676957
• Report Number: MW5116734
• Device Sequence Number: 1
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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
• Treatment: EXTENSTION SET/TUBINGEPOPROSTENAL
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR
• Patient Sex: Female