MAUDE Adverse Event Report: CAREFUSION, INC VENTILATOR, HIGH FREQUENCY; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number FLEXIBLE CIRCUIT 51 IN HEATED WIRE F&P 730

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, carefusion has not received the suspect device/component from the customer for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The patient was connected to the 3100a ventilator for five (5) days.The patient was being moved from supine to prone position and as the patient was turned, the airway pressure line sheared off from the wye piece of the patient circuit.There was no patient impact.The patient remained stable following the incident.

Manufacturer Narrative

The carefusion manufacturing plant received the suspect component, a 3100a patient circuit.The device was received in a condition making the evaluation of the device not possible.The device is no longer available for evaluation.

• Brand Name: VENTILATOR, HIGH FREQUENCY
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION, INC; yorba linda CA
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6097710
• MDR Text Key: 59734552
• Report Number: 2021710-2016-04832
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLEXIBLE CIRCUIT 51 IN HEATED WIRE F&P 730
• Device Catalogue Number: 771375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 3100B VENTILATOR
• Patient Outcome(s): Required Intervention