MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7308-24

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2022

Event Type  Injury  

Event Description

Patient receives 5-fluorouracil infusions via cadd pumps.Twice now, cadd pump has leaked chemotherapy onto the patient.The drug reservoir/cassette appears to leak in the top corner where tubing is attached.Infusystem (cadd servicer) representative thought it might be a defect in the glue where this plastic bag is sealed.Lot# identified as 4276311.Manufacturer smiths medical.Fda safety report id# (b)(4).

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 15300726
• MDR Text Key: 298830875
• Report Number: MW5111722
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7308-24
• Device Lot Number: 4276311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White