MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient reported both pumps showed no disposable tubing found.Patient was able to replace both tubing and cassette and issue was resolved.Lot or product not available.No further information found.Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contribute to patient or clinical injury? no; is the actual device available for investigation? no; did we replace device? yes; did the patient have a backup device they were able to switch to? yes; if yes, was the patient able to successfully continue their infusion? yes; is the infusion life-sustaining? yes; what is the outcome of the event? resolved.Reported to (b)(6)/caremark by pt/caregiver.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12648240
• MDR Text Key: 277129984
• Report Number: MW5104664
• Device Sequence Number: 2
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/17/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1