MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; STOPCOCK, I.V. SET

Model Number MC33892

Device Problem Defective Component (2292)

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

Event Date 01/11/2021

Event Type  malfunction  

Event Description

Closed medication set hung with 250cc of normal saline infused 14 hours later, unintentionally.New 250cc bag hung and was empty 12 hours later, also unintentionally.Patient received 500cc of normal saline.Md notified.No changes made to plan of care.No harm came to patient.Patient continues to receive prn lasix.Product issue notification form completed and submitted with tubing to materials management.The tubing is a closed system only used on this unit.Prevent having to open up lines in compromised patients tubing.Tubing attaches to the patient and stays attached, half way up tubing is an area for a syringe and looks like syringe tubing that stays attached and is for medication delivery, it stays on pump when not in use.Also, there is also a one-way valve that is on the tubing that should prevent any higher up fluid from infusing from the flush bag of saline solution which is at the top other end of the tubing.There is a clamp under the flush bag at the top of the tubing but is reportedly not clamped because with the one way valve there is not thought to be a way that the fluid would just flow, generally to get the fluid out of the top flush bag you need to pull on the syringe below to pull the flush from the bag.With the one-way valve nothing should be able to free flow, tubing was set up correctly.The only possibility is that the valve had an issue.Has not occurred before.Discussed w/ clinician: sent to materials management for return to company- done.Discussed issue with company rep also will follow up to see if the clamp right below the flush bag should and could be clamped all the time when not in use- clinician.Will do medsun maude search once have the reference numbers etc- sr: ref# mc33892 107" transfer set w/dual check valve, microclave clear, rotatating luer.

• Brand Name: ICU MEDICAL
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11222391
• MDR Text Key: 228413838
• Report Number: 11222391
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MC33892
• Device Catalogue Number: REF# MC33892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1460 DA
• Patient Weight: 23