MAUDE Adverse Event Report: CAREFUSION, INC 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number FISHER & PAYKEL MR850 HUMIDIFIER FLEXIBLE CIRCUIT WITH SHORT HEATED WIRE

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

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion has received the suspect device, a fisher & paykel mr850 humidifier flexible circuit with short heated wire.Upon completion of the device evaluation, a follow-up report will be submitted.

Event Description

The customer reported that the circuit tube (the tube going from the humidifier to the circuit) became loose at the circuit, while the device was in use on a patient.The patient experienced heart rate deceleration and oxygen desaturation and required aggressive manual ventilation.The circuit had to be replaced due to low pressure on the oscillator pressure and the circuit continuing to come apart.

Manufacturer Narrative

Additional information: (catalog number of part received for evaluation is different than the catalog number reported by the customer, which was included on the initial report).Results of investigation: the carefusion manufacturing plant received the suspect component, a 3100a fisher & paykel mr850 humidifier flexible filtered circuit with heated wire, and evaluated the device.An evaluation of the component did not confirm the reported issue as the sample was received assembled and manipulated.The reported issue was recreated by pulling the tube to try to disconnect it from the connector, this required a lot of force to be applied to separate the tube from the connector.The connector was dimensionally inspected and found to be within manufacturer's specifications.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: 6355341
• MDR Text Key: 68212662
• Report Number: 8030673-2017-00284
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

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: FISHER & PAYKEL MR850 HUMIDIFIER FLEXIBLE CIRCUIT WITH SHORT HEATED WIRE
• Device Catalogue Number: 16390-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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
• Patient Outcome(s): Required Intervention