MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-EXTENSION SET; SET, I.V. FLUID TRANSFER

Device Problems Device Alarm System (1012); Device Sensing Problem (2917)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

Spontaneous communication.Patient reported that "high pressure" alarm was going off on her pump.Patient stated that she changed her cassette at 6:40 pm this evening with no issues, but the alarm started going off at around 8 pm.Patient removed the pump from the pouch, checked the pump and it stopped right as she was checking it.Patient reported the pump seemed very "sensitive to movement''.The alarm was going off with some but not all of her movements.Pharmacist trouble shot with patient while on phone and confirmed new batteries were in device, tubing was not attached backwards and no kinks/obstructions in the tubing.Patient could not identify any tubing issues but was able/wanted to try changing tubing before changing pumps.Patient attached new tubing while on phone with pharmacist and alarm stopped sounding.Lot: 4303046, expiration date 09/12/2023.Patient was advised to cal back immediate if issue occurs again.Pt verbally understood.No additional info at this time.Dose or amount: treprostinil 128/kg/min.Pump return tracking information is not applicable to event.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of pump when alarm occurred is not known.No add'l info is available at this time.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? no.Is the actual device available for investigation? yes.Did we [mfr] replace the device? no.Pt had add'l tubing; did the pt have a backup product they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion ? yes.Is the infusion life sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: CADD-EXTENSION SET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16095107
• MDR Text Key: 306724304
• Report Number: MW5114151
• Device Sequence Number: 1
• Product Code: LHI
• 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: 12/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female