MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE CLEAR, R; STOPCOCK, I.V. SET

Model Number MC33892

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

A medsun mandatory medwatch report was received that stated, "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 patient's 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 not 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." additional information received that the event occurred in the patient room at the hospital and the original intended procedure was closed system normal saline bag on top should not infuse, used for flush only.There was patient involvement and no adverse event and no delay in therapy.

Event Description

Additional information received that stated the reported issues did not result in any patient/operator injuries and or adverse consequences.There were no issues noted during initial set-up/priming.The closed med set was "y¿ed" into alaris continuous tubing set which was infusing at 2cc/hr continuously.Alcohol caps were in place on the alaris tubing at connection points that were not in use.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.The reported complaint cannot be confirmed based on the information that has been provided.Additional information in sections b5, d9, d10.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE CLEAR, R
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; . 22790 ; MX 22790
• MDR Report Key: 11375033
• MDR Text Key: 254301722
• Report Number: 9617594-2021-00048
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC33892
• Device Catalogue Number: MC33892
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE, MFR UNK; TUBING SET, BD ALARIS MFR
• Patient Age: 4 YR
• Patient Weight: 23