MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD CASSETTE 100ML W/FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4103163

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 06/18/2021

Event Type  malfunction  

Event Description

Outbound.Spouse one of cadd cassette 100ml w/flowstop alarmed.No disposable on both pumps, changing over to new cassette resolved alarm.Resol 63 ml, pump rate 50 ml/24h.Lot# 4103163.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 12129964
• MDR Text Key: 260484728
• Report Number: MW5102311
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 4103163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR