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

Model Number 21710624

Device Problem Fluid/Blood Leak (1250)

Patient Problems Nausea (1970); Dizziness (2194)

Event Type  Injury  

Event Description

Spontaneous call.Patient reported a leak in line.Patient reported that she woke up feeling extremely nauseous.She went to the bathroom and noticed her shirt was wet from the medication leaking.From patient explanation, it seems the leak was from the ext set tubing connector.Patient stated that she began to feel dizzy after starting the pump but believed it was her "in her head".Patient did not want t stop the pump and go to the emergency room.Patient requested call back in 30 minutes for a check in.Author made outbound to patient 30 minutes later for check in.Patient confirmed she feels much better and less dizzy.Patient spoke to md and md instructed to continue at current dose.Lot/sn of ext set not provided no other information available at this time.Product lot number and expiration date were systematically retrieved from the dispensing system.No add'l info, details, or dates available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unk.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? yes, interruption in therapy and side effects when restraining.If yes, was any medical intervention provided? no.Is the actual device available for investigation? no.Did we replace the device? no.Did the pt have a backup device they were albe to switch to? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD EXT SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, INC.
• MDR Report Key: 16336335
• MDR Text Key: 309267709
• Report Number: MW5114796
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 02/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21710624
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female