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

Model Number UNKNOWN

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

Per nursing program manager (b)(6): the patient and i mixed a new cassette, and upon priming it, the pump alarmed high pressure.It was not attached to the pt yet and all clamps were unclamped.We tried her secondary pump and it alarmed high pressure as well.This makes me think that it is a faulty cassette.The pt received a new broviac catheter and we would like her to transition to her home pump so we can make sure the line is functional.She now has tachycardia and other issues that will keep her hospitalized for a few more days.Cassette lot number not provided.Exact dates and length of stay of hospitalization unknown.Patient uses intravenous treprostinil via cadd legacy pump, self mix.No further information available.Photographs were not provided.This is a continuous infusion.Set flow rate & volume delivered are unknown.Position of the pump when event occurred is unknown.No additional info, details, or dates available.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? yes, if yes, was any medical intervention provided? yes- hospitalization due to tachycardia, is the actual cassette available for investigation? unknown, did we replace the cassette? yes, pending shipment, did the patient have additional cassettes they were able to switch to? yes, if yes was the patient able to successfully continue their infusion? yes, if no, what was the patient instructed to do in able to continue their infusion? not applicable, is the infusion life-sustaining? yes, what is the outcome of the event? ongoing, resolved?, ongoing? ongoing.Reported to (b)(6) by: health professional.

• Brand Name: CASSETTE MEDI RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17424684
• MDR Text Key: 320171354
• Report Number: MW5120338
• 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: 07/26/2023

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
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Patient Sequence Number: 1
• Treatment: BROVIAC CATHETER.
• Patient Outcome(s): Hospitalization
• Patient Sex: Female