MAUDE Adverse Event Report: MERCURY MEDICAL T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number M1091316VS

Device Problems Occlusion Within Device (1423); Use of Device Problem (1670); No Flow (2991)

Patient Problems Asphyxia (1851); Hypoxia (1918); Brain Injury (2219)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

Cfn-2015-5871.To date the actual complaint device has not been made available to carefusion for further evaluation.A follow up mdr will be sent once the investigation is complete.

Event Description

The following was initially reported to carefusion: "cap placed on circuit then facemask attached, flow was not delivered to neonate.Neonate became hypoxic and had brain injury." additional information was obtained regarding the event.The cap on the vital signs t piece was placed onto the circuit then the facemask was fitted.This occluded the circuit and stopped the oxygen being delivered to the neonate.Neonate became hypoxic and had brain injury.The trust medical director has reported this incident to the mhra.It was indicated that samples are available and are currently with the end user.The customer was asked to confirm if there was a brain injury to the neonate as a result of the hypoxia condition.The customer indicated that the patient has gone home and they did not know the long term effects.

Manufacturer Narrative

(b)(4).The t-piece neonatal patient circuit kit device is manufactured by mercury medical.This device was approved for market under fda 510k #k093913.Since its introduction, a protective cap was added in 2012 at the request of the clinical market to aid in preventing contaminant collection.This feature is a standard feature on many predicate devices and is to be removed prior to use.This device is to be used by a trained and qualified clinician (i.E.Prescription use only).The cap and t-piece valves are manufactured to be standard iso 15mm fittings.However, the mask is made of a pliable silicone material.If inappropriately and forcibly manipulated, the mask may be inadvertently inserted into the t-piece cap.As a result, the device would be occluded resulting in device failure and potential patient injury.In addition, the current directions for use (dfu) do not provide a warning regarding this potential error.Approximately (b)(4) units have been sold to date with this feature.There have only been three complaints received related to the failure to remove the cap prior to inserting a mask on the t-piece.This represents a (b)(4) failure rate.Mercury medical has enhanced the device by adding "ribs" to the protective cap to prevent accidental insertion of a mask into the port.In addition, the dfu has been updated to include a statement to inform the user to remove the protective cap prior to testing/patient use.Mercury medical has also initiated a recall for this product.The recall involves a field safety notice (fsn) being sent to all customers to notify users of this potential harm.In addition, the recall also involves sending caution labels to all customers for attachment to all affected product currently in their inventory.

Manufacturer Narrative

This product is manufactured for carefusion by mercury medical.Mercury medical is the legal manufacturer of the device.Carefusion does not own the design, specifications, or regulatory pathway for the device.The device is labeled as a carefusion product and is sold and marketed by carefusion.

• Brand Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th street north; clearwater FL 33762
• Manufacturer (Section G): CAREFUSION 2200, INC; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer Contact: jill rittorno ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 8473628056
• MDR Report Key: 5110702
• MDR Text Key: 27023646
• Report Number: 2050001-2015-00025
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Followup,Followup
• Report Date: 09/29/2015,12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M1091316VS
• Device Lot Number: 14252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Distributor Facility Aware Date: 09/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1024404-10-20-2015-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability