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

Lot Number 4196377

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous communication, per patient, she was getting high pressure alarm on her legacy pump even before it was attached to her body.Patient switched to a new tubing and the pump began working with no issues.Malfunctioning cadd ext set lot 4196377, exp: 09/13/2026.No other information known.Prescriber has not been notified.Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual tubing available for investigation? no; did we [mfr] replace the tubing? no; did the pt have add'l tubing they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 13720902
• MDR Text Key: 287029339
• Report Number: MW5108007
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 4196377
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female