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

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt reported that her cassette would not fit into pump and she was unable to use.Lot number for cassette unknown.Patient made new cassette and it ran fine.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? no; did we replace the cassette? yes; 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.All known info and/or dates are contained on this form.If any additional information and/or dates are received they will be provided in a separate report.Reported to (b)(6) by pt/caregiver.

• Brand Name: MEDI RESERVOIR CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13720918
• MDR Text Key: 287029387
• Report Number: MW5108008
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female