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

Device Problem Nonstandard Device (1420)

Patient Problem Diarrhea (1811)

Event Type  Injury  

Event Description

Called the pt to discuss the current recall of cadd cassettes and she informed me that she is in the hospital.She said that she does not have any cassettes with her and her roommate has been mixing them and bringing them to her in the hospital.She said that she would call us to review the lot numbers once she is out of the hospital.She said this would be the easiest thing to do for her.She was admitted to the hospital on (b)(6) 2023 because she had been having significant diarrhea for a week straight.She is not sure if her doctor is aware of the hospitalization.She had no questions and no additional information was disclosed.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD CASSETTE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17298837
• MDR Text Key: 318929266
• Report Number: MW5119259
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 07/03/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2023
• Patient Sequence Number: 1
• Treatment: EPOPROSTENOL SDV G-VELETRI
• Patient Outcome(s): Hospitalization
• Patient Sex: Female