MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOLOCK ADDITIVE PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL-12

Device Problems Material Fragmentation (1261); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/18/2021

Event Type  Injury  

Event Description

When bag dry spike with icu medical's chemolock additive port (cl-12) was affixed to bd alaris low sorbing administration set (ref #(b)(4)), there is a potential for coring to occur, this became visible in the drop chamber of the tubing set, and may occur at any time during administration.We witnessed this on the patient towards end of 3 hour infusion.This has happened on two separate occasions with same devices but different medications.We stopped the infusion immediately and do not believe any of the floating 2mm size plastic particulates in the line were infused into the patient.Patient did not have any complaints or other adverse effects from this occurrence.Test completed to ensure aseptic infusion conditions were maintained.Fda safety report id # (b)(4).

• Brand Name: CHEMOLOCK ADDITIVE PORT
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 12924277
• MDR Text Key: 281742665
• Report Number: MW5105745
• Device Sequence Number: 1
• Product Code: ONB
• 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: 11/30/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL-12
• Device Lot Number: 5489842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD ALARIS LOW SORBING IV ADMIN SET
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White