MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE 100ML W/FLOWSTOP; SET IV FLUID TRANSFER

Lot Number 368994

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Inbound, one of patient¿s cadd legacy cassettes caused alarm of no disposable pump, won¿t run on either pump.Changed over to new cassette and alarm resolved.No further details provided, lot # 368994.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET IV FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 8396303
• MDR Text Key: 138215787
• Report Number: MW5084691
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 02/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 368994
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1