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

Device Problem Failure to Prime (1492)

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

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Outbound call made to pt.Premix patient didn't received shipment and had to mill from her emergency kit.When i was able to connect with patient she reported she wasn't able to get her first cassette primed and was in the process of milling a second cassette.Unknown if original cassette faulty or if inability to prime was user error.The reported product fault did not occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The cassette is available to be returned for investigation.The event is resolved.Describe in detail any, and all damage to the cassette: no damage reported.This incident has not happened within the past 6 months.This patient has reported a pump malfunction within the past 6 months.Pt reported as product problem, unsure if actually product use error; no add'l info, details or dates are available at this time.Return tracking info is not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual cassette available for investigation? yes; did we replace the cassette? not at time of writing; did the pt have add'l cassettes they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes; is the infusion life sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15419640
• MDR Text Key: 300069827
• Report Number: MW5112036
• 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: 09/07/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2022
• Patient Sequence Number: 1
• Treatment: REMODULIN ; TADALAFIL
• Patient Age: 65 YR
• Patient Sex: Female