MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DISPOSABLE PATIENT CIRCUIT KIT; VENTILATOR CIRCUIT

Device Problem Circuit Failure (1089)

Patient Problems Cardiopulmonary Arrest (1765); Low Oxygen Saturation (2477)

Event Date 12/08/2017

Event Type  Injury  

Event Description

A (b)(6) year old female to the hospital for cva and was intubated and required an mri.Went to mri suit where patient was changed over to the mri safe ventilator and circuit.After being placed on mri vent and circuit the patient started to desaturate and coded after approximately 8 minutes.This caused patient to fall outside treatment window.It was reported the ventilator malfunctioned but the ventilator was checked with no issues found.The used circuit was sequestered by risk and biomed found the et adaptor was attached to the circuit tubing backwards.(both ends of the et adaptor piece are approximately the same size and easily fit into circuit tubing either way).The adaptor piece dose have printed on it patient but is difficult to see.This is being turned in as a safety issue with the adaptor piece easily attachable to the circuit tubing.When this piece is hooked up backwards the patients are not able to get any oxygen due to the one way valve.During the investigation the mri tech pulled the circuit that was already connected together.It was discovered during the investigation that some of the circuits require assembly and others are already assembled.Unfortunately the packaging for this event was not saved so no lot numbers available.

• Brand Name: DISPOSABLE PATIENT CIRCUIT KIT
• Type of Device: VENTILATOR CIRCUIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC. ; 1265 grey fox road; st. paul MN 5512
• MDR Report Key: 7165229
• MDR Text Key: 96466245
• Report Number: 7165229
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Distributor Facility Aware Date: 12/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR