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

Device Problem Device Sensing Problem (2917)

Patient Problems Fatigue (1849); Decreased Appetite (4569)

Event Type  Injury  

Event Description

Patient's spouse reports that patient continues to have loss of appetite and tiredness.Also states they had a cassette malfunction and cassette was not "recognized by the pump".They made a new cassette and the issue was solved.No serial or lot numbers available.No other info is known at this time.The cassette is not available for return.Photographs were not provided.Set flow rate and volume delivered are unknown.Unknown if there was an alarm.This is a continuous infusion.Return tracking information is not available.No additional information is available at this time.Did the reported product fault occur while in use with the pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual product available for investigation? no; did we [mfr] replace the cassette? no; did the pt have additional 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: 16294852
• MDR Text Key: 308885822
• Report Number: MW5114656
• 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: 01/30/2023

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: 02/02/2023
• Patient Sequence Number: 1
• Treatment: TREPROSTINIL
• Patient Sex: Male