MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL 2.5 MM LIFEPORT ADAPTER; 2.5 MM LPA

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problem Pneumothorax (2012)

Event Date 01/10/2015

Event Type  No Answer Provided  

Event Description

Event occurred on (b)(6) 2015; however, bunnell, inc was not made aware of the event until the medwatch report submitted by the customer was received from the fda on (b)(6) 2015.Event information from clinical hotline call, provided by bunnell clinical specialist: customer called bunnell's hotline at 10:58 pm.At that time the customer reported that the patient had 2 chest tubes and had received needle aspiration, all prior to consulting bunnell.Bunnell's clinical specialist reviewed the patient and set-up with the therapist.The patient was intubated with a 3.0 mm ett.Bunnell's representative let the therapist know that bunnell recommends using the 3.5 mm lifeport adapter (lpa) on a 3.0 ett rather than the 2.5 mm lpa.The therapist was advised to change the lpa size to the 3.5 mm lpa.As confirmed by the customer's report, when the set-up was changed the servo pressure returned to its original baseline.Event information provided verbatim from customer report, for reference only: respiratory therapist was told in a report, that the servo pressure on a high frequency jet ventilator (hfjv) was measuring at 6-7 all day.The therapist was called to the bedside by nurse to administer surfactant.They noticed that the servo pressure was measuring 4.3.Later that day, the respiratory therapist was called again to place inhalation inline with hfjv.At that time they notices the servo pressure was measuring 5.6.A few hours later, a pneumothorax was confirmed by x-rays and the therapist then noticed the servo pressure was at 7.4-8.6.They notified the nnp and he told rt that they were performing a needle aspiration and chest tube on the right.Then, the respiratory therapist came by to do the q2 check and noticed the servo pressure was still 8.8-9.1.The therapist then called bunnell's hotline and asked for advice from the manufacturer.Bunnell (manufacturer) 3.5 adaptor from the 2.5 one.Therapist called the other respiratory therapist on duty and she assisted in changing out the adapter.Patient tolerated the procedure fairly well.Oxygen saturation (sats) did drop in the 60 and 80s with bagging but responded well after placed back on hfjv with inhalation.Sats returned to 99 and 100.Immediately after placing pt back on hfjv, the servo pressure returned to 4.2-4.3 the rest of the shift.

Manufacturer Narrative

The primary issue here was changing out the lifeport adapter (lpa) for a new one, not changing the adapter size from 2.5mm to 3.5mm.The lpa that was on the pt likely had secretions in it that interfered with the pressure readings.In this situation the pip appears to the life pulse hfv as low.Therefore, it compensates by increasing the servo pressure to bring the monitored pip back up to its set point.Servo pressure response is limited by its upper and lower alarms.The maximum amount the servo pressure can increase with the upper limit active is 1 psi.If the servo pressure increases by more than 1 psi the upper and lower limits had to be reset by the clinician at the bedside by pressing the enter button or reset button.No pressure monitoring issue would allow the upper limit to be exceeded.If servo pressure reaches the upper limit the system alarms and servo pressure is capped.In order for servo pressure to continue to increase, beyond the upper alarm limit, the alarm limits would need to be reset manually by the user or by the user pressing the enter or reset buttons.Not recognizing that an increase in servo pressure of 1 psi or more is inappropriate allowed the pt to be exposed to tidal volumes that were larger than needed.Resetting alarm limits without proper troubleshooting is ill advised.The following warnings are identified within the lifepulse high frequency ventilator operator's manual: warning: an audible alarm indicates an anomalous condition and should never go unheeded.Warning: pressing the enter button during an alarm will temporarily silence the audible alarm and cause the machine to restart its efforts to ventilate the patient under alarm conditions.The risk in such a procedure is that it allows an operator to restart ventilation without first correcting the existing alarm condition.It is likely that, in this case, these warnings were not properly headed.Rather a servo pressure alarm condition occurred and ventilation was resumed without proper alarm troubleshooting.Bunnell's "instructions for use of lifeport endotracheal tube adapter" (bunnell part number 01817-03), which is included with each box of lifeports and each patient circuit kit, states: "each size lifeport is designed to be used with two endotracheal tube sizes, the same sized i.D.And the 0.5mm size smaller.For example, the 3.5 mm i.D.Lifeport can be used with a 3.0 or 3.5 mm i.D.Endotracheal tube." additionally, the operator's manual for the lifepulse hfv (bunnell part number 01773-27) states that the user is to "use the same or half-size larger lifeport adapter on the et tube (e.G., use a 3.5 lifeport adapter on a 3.0 and 3.5 et tube).".

• Brand Name: BUNNELL 2.5 MM LIFEPORT ADAPTER
• Type of Device: 2.5 MM LPA
• Manufacturer (Section D): BUNNELL, INC.; salt lake city UT
• Manufacturer Contact: curtis olsen ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 4664935
• MDR Text Key: 5683923
• Report Number: 1719232-2015-00002
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 1 MO