MAUDE Adverse Event Report: CAREFUSION CIRCUIT 6FT HTD SINGLE LIMB ADULT 20/CS; CIRCULATOR, BREATHING-CIRCUIT

Model Number RT600-850

Device Problems Unintended Ejection (1234); Fitting Problem (2183); Device Displays Incorrect Message (2591)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4)- initial emdr submission.Carefusion is awaiting the sample return from the customer.Multiple attempts have been made by customer advocacy to gain the sample.A ups label was provided to customer for the sample return, but to date the sample has not been received.The customer is unable to provide the lot number for the affected product.The customer states they are no longer using this product.If any additional information or if a sample becomes available a follow up emdr will be submitted.

Event Description

Customer reported via email: "the issue is that we use f&p heater/humidifiers with our high-flow oxygen systems.The f&p temp probe that fits into the airlife rt600-850 circuit just above the heater port keeps popping out while in use because it's just a friction-fit connection and does not have a little latch that secures the probe.When that happens in use, the patient loses a significant part of the flow from the device and oxygen desaturation can occur.There was not any actual patient impact or harm related to this issue, the clinician was alerted by the spo2 alarm when the spo2 would go below 90%.This product is used when the patient is receiving high flow oxygen via nasal cannula.The clinician would then reconnect the temp probe into this circuit to fix the issue.I do not have the lot number, and we are no longer using this product.We have switched to an f&p circuit that provides a clip to keep the temperature probe from coming out of the circuit".

• Brand Name: CIRCUIT 6FT HTD SINGLE LIMB ADULT 20/CS
• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5391468
• MDR Text Key: 37431106
• Report Number: 8030673-2016-00149
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: RT600-850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1