MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; RESERVOIR, CASSETTE

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Information was received regarding a cadd reservoir cassette.It was reported that the patient had another syncopal episode on sunday morning, (b)(6) 2021.She feel, hit her head, and injured her tail bone.Patient was sitting on the couch, got up to go to the kitchen, and about half way there, she fell.The iv pump did not alarm prior to this episode.Patient reached out to the md's office right away and was sent to the emergency department.She resides 3 hours away from the hospital, and on the way to the hospital, the pump alarmed so the patient stopped to change it.The alarm was 1 hour post syncopal episode.Patient reported that the cassette was empty.She noted that she was to have 4 hours remaining on the cassette.But at the time, patient changed the pump to a new pump.No further details provided at this time.

• Brand Name: CADD
• Type of Device: RESERVOIR, CASSETTE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12687943
• MDR Text Key: 278078180
• Report Number: 3012307300-2021-10202
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/25/2021

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 Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1