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

Lot Number 4220003

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Inbound; both legacy pumps alarming no disposable with same cassette.Advised to mix new cassette, attempt infusion again.Pt declines nurse offer to stay on line, will call back; pt anxious to restart infusion.No lot info collected at this time; will obtain during return call.No further details provided.New cassette infusing without issue on initial pump that alarmed, affected cassette lot number 4220003, exp 11/24/2022, to call back if further issues.No further details provided.

• Brand Name: CADD CASSETTE 100ML W/FLOWSTOP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14288564
• MDR Text Key: 290958242
• Report Number: MW5109541
• Device Sequence Number: 1
• Product Code: LHI
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/24/2022
• Device Lot Number: 4220003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Patient Sequence Number: 1
• Treatment: LEGACY PUMPS
• Patient Age: 69 YR
• Patient Sex: Female