MAUDE Adverse Event Report: CAREFUSION 211. INC. CIRCUIT ADULT DUAL HEATER WITH CHAMBER

Catalog Number ISG2026031

Device Problem Disconnection (1171)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 03/11/2016

Event Type  malfunction  

Event Description

There was a new vent circuit on the vent.While on transport, the heater probe became disconnected from the heater port.The patient had a slight increase work of breathing and oxygen desaturation.The respiratory therapist re-inserted the probe.There was no harm to the patient.It was also noted that on wednesday, (b)(6) there was another occurrence of the heater probe "popping out" on another trauma patient.Action plan: respiratory therapy met with the company representatives.We have decided to discontinue use of this product due to ongoing problems.Manufacturer response for circuit adult dual heater with chamber, circuit adult dual heater with chamber (per site reporter): recommended that we double check connections when vent is checked.

• Brand Name: CIRCUIT ADULT DUAL HEATER WITH CHAMBER
• Type of Device: CIRCUIT ADULT DUAL HEATER WITH CHAMBER
• Manufacturer (Section D): CAREFUSION 211. INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5528779
• MDR Text Key: 41309157
• Report Number: 5528779
• Device Sequence Number: 1
• Product Code: BTT
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ISG2026031
• Device Lot Number: 22020653
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR