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

Catalog Number ISG2026031

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  malfunction  

Event Description

The respiratory therapist observed that the heater probe became disconnected (popped out) from the heater pot.The patient did have decreased respiratory status during this time.Medications were administered to the patient and the probe was re-inserted.Appropriate interventions were taken by the therapist.Action plan: respiratory therapy met with company representatives regarding this and other similar events that have occurred with this product.We are discontinuing use of this product and converting back to our previous used circuit vent product.Manufacturer response for circuit adult dual heated with chamber, circuit adult dual heater with chamber (per site reporter): that we need to double check the connections when we do our vent checks.

• Brand Name: CIRCUIT ADULT DUAL HEATER WITH CHAMBER
• Type of Device: CIRCUIT ADULT DUAL HEATED WITH CHAMBER
• Manufacturer (Section D): CAREFUSION 211. INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 5528788
• MDR Text Key: 41234987
• Report Number: 5528788
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ISG2026031
• Device Lot Number: 22020653
• Was Device Available for Evaluation?: Yes
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2016
• 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 Outcome(s): Other
• Patient Age: 62 YR