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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Decreased Appetite (4569)

Event Date 06/24/2022

Event Type  Injury  

Event Description

Spontaneous call from patient's wife who reported loss of appetite since the last dose increase on (b)(6) 2022.Patient just does not feel hungry.One cassette malfunctioned on same day (b)(6) 2022 where pump was stating a kink in the line.Patient's wife assured there was no blockage.The patient made a new mix and tried on both pumps which worked fine.No adverse effects reported the cassette is not available for return per wife.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 cassette available for investigation? no; did we [mfr] replace the cassette? no; 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: 14914747
• MDR Text Key: 295359433
• Report Number: MW5110662
• 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: 06/29/2022

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: 07/01/2022
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male