MAUDE Adverse Event Report: SMITH'S MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7349-24

Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  Injury  

Event Description

Patient was receiving blincyto continuous infusion provided by ambulatory cadd solis pump for use in the home.Patient presented to clinic on (b)(6) 2022 for bag change of blincyto continuous infusion.At time of bag change, blincyto medication bag contained greater than the volume estimated that should have been present at this time (~300ml in bag compared to estimated amount of 20-30mls).Clinic staff notified pharmacy and physician group and patient was admitted due to likelihood that infusion had been stopped for > 4 hours and for an unknown amount of time.Patient reported no alarms of pump.Staff checked pump event history to confirm that no interruptions were documented on cadd solis pump.Bag and pump were returned to pharmacy.New sample bag and tubing was placed on pump that had been with patient during this event, pump worked without issue and alarmed for occlusions and air in line when tested.Bag and tubing that patient had during event was connected to a new pump.Identified that presumed issue is with tubing that was attached to this bag, we observed that fluid would move back and forth in the tubing, without making progression down the tubing.No occlusion errors alarmed during this time.Tubing used was product 21-7349-24 cadd administration set our pharmacy has 2 lots of 21-7349-24 and either could have been sent to this patient: lot: 4232326, exp 2026-12-29; lot: 4266292, exp 2027-03-29.Fda safety report id# (b)(4).

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITH'S MEDICAL ASD, INC.; minneapolis MN 55442
• MDR Report Key: 15121641
• MDR Text Key: 296871232
• Report Number: MW5111160
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7349-24
• Device Lot Number: 4232326 OR 4266292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD SOLIS PUMP- 07/19/2022-07/21/2022
• Patient Outcome(s): Hospitalization
• Patient Age: 33 MO
• Patient Sex: Female
• Patient Weight: 12 KG