MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX FOUR-WAY HI-FLO STOPCOCK; STOPCOCK, I.V. SET

Model Number MX9341L

Device Problems Device Dislodged or Dislocated (2923); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 05/29/2021

Event Type  malfunction  

Event Description

Transducer tubing attached to negative side of the extracorporeal membrane oxygenation (ecmo) circuit disconnected from the transducer which lead to air in the circuit and an ecmo code.Transducers are necessary to monitor the ecmo circuit including on the negative side of the circuit.If anything is open on the negative side, then air can suck into the circuit.Verify transducer tubings are connected securely to transducer with standard shift safety checks.During negative pressure transducer safety check tubing, as pressure transducer was placed on the holder tubing dislodged causing air entering circuit.Ecmo specialist on the circuit, acted quickly took patient off the support and initiated ecmo code.Inspection of the circuit showed air only on venous tubing and pre oxygenator side of the membrane.No air was noted on post oxygenator side of the membrane, arterial tubing and patient's arterial cannula.During ecmo circuit rescue, patient was supported by medical team.It was decided to use new circuit to reinitiated ecmo support.Stopcocks and transducers connections that rotate at the lure connection are problematic.These connections can potentially come off loose.As quality improvement, all custom pack ecmo circuits stopcocks were changed to none rotating.Ecmo circuit uses hospital wide transducers.All three pressure monitoring on ecmo circuit are essential tools that allow ecmo team make appropriate diagnosis and treatment about patient and circuit.Suggestion: find a different transducer for ecmo circuit that does not have a rotating lure connection.This event had 2 different products involved.

• Brand Name: MEDEX FOUR-WAY HI-FLO STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings rd.; dublin OH 43016
• MDR Report Key: 11998986
• MDR Text Key: 256191057
• Report Number: 11998986
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX9341L
• Device Lot Number: 3871762
• 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: 06/09/2021
• Date Report to Manufacturer: 06/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA