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

Lot Number 4220000

Device Problems Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Outbound.Patient reported no disposable clamp tubing alarm on cadd legacy pump (b)(6) 2022 with half full remodulin cassette lot 4220000 that patient resolved by pushing inner bag plastic further inside cassette.Patient reported cadd legacy pump fell during troubleshooting and hit floor.Serial number (b)(4).Pump replaced and pt advised to return.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: 14137200
• MDR Text Key: 289687062
• Report Number: MW5109088
• 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: 03/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4220000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female