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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Fatigue (1849)

Event Type  Injury  

Event Description

Spontaneous call i spoke with pt, she is from (b)(6) now in (b)(6).She brought only one pump she forgot the 2nd one.Pt stated an error msg no disposal pump won't run, pt tried to align the cassette to the pump and did change a new cassette, pt stated this problem happened before and she knows about to align the cassette to the pump but this time it didn't work, sn# (b)(6), will courier a new pump for today but i advised pt that it can take more than 4 hrs and i advised pt to go to the hospital.Pt stated she was told to lay down and have her o2, pt stated she will wait 4 hours and then go to the hospital.Pt stated infusion stopped and she just feeling a little bit tired.Pump return tracking information is not available.Photographs were not provided.This is a continuous infusion set flow rate and volume delivered are unknown.No additional information is available at this time.Did the patient have a backup device they were able to switch to? no.If yes, was the patient able to successfully continue their infusion? no.If no, what was the patient instructed to do in able to continue their infusion? to go to the hospital."is the infusion life-sustaining? no".What is the outcome of the event? resolved.Ongoing? ongoing.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? no".If yes, was any medical intervention provided? please explain."is the actual device available to be returned for investigation? yes."did we replace device? will courier for today".Reported to cvs/caremark by: patient/caregiver.Reference report: mw5117776.

• Brand Name: CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 16992975
• MDR Text Key: 315882491
• Report Number: MW5117777
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN.
• Patient Sex: Female