MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL 100 ML CADD MEDICATION CASSETTE RESERVOIR WITH FLOW STOP (SMITHS; SET, I.V. FLUID TRANSFER

Model Number 21-7002-24

Device Problems Device Alarm System (1012); Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

Patient's infusion pump was prepared, connected and started without incident patient discharged home pump began rapid alarming ~32 hours after start of pump at around 8pm.Patient called the infusystem help line as instructed and was told to stop infusion and turn of pump and to call the scs infusion in the morning patient came to infusion center the next morning.Pump turned back on.Rapid beeping continued and "no disposable" warning briefly flashed on screen.A check of pump revealed that a correct amount of "given" medication for the timeframe was recorded as dispensed and the remaining reservoir volume appeared correct as well.Pharmacy staff turned off pump and cassette was removed and remounted (same cassette) and batteries were changed.No alarms were going off when pump restarted.Pump hooked up to patient and run for an hour while patient waited.Pump appeared to be functioning and recording volume dispensed properly so patient was again discharged and told to return in 11 hours patient returned next day and experienced no more alarms but rn noticed that reservoir was completely empty and pump appeared to have continued pumping air into line, about halfway to port but no air contact with patient.The pump also registered that >100ml had been dispensed though the start amount had been ~90ml pump disconnected and no issues reported by patient dr.(b)(4) informed of deviation in infusion time and rl was submitted to (b)(6) for review.Upon contacting infusystem it was discovered that recently infusystem has become aware of an increase in no disposable alarms (nda) on the cadd legacy devices when using the smiths medical 100 ml cadd medication cassette reservoir with flow stop (smiths medical #21-7302-24).The alarm is occurring at the beginning or middle of infusion, resulting in a possible interruption of the patient's therapy.There are no recalls for this device at this time.Fda safety report id# (b)(4).

• Brand Name: SMITHS MEDICAL 100 ML CADD MEDICATION CASSETTE RESERVOIR WITH FLOW STOP (SMITHS
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 12049522
• MDR Text Key: 258140847
• Report Number: MW5102020
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7002-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 67