Patient Circuit used with the Life Pulse High Frequency… recallZ-0514-2013 · Bunnell, Inc. · initiated Nov 19, 2012

Why it was recalled

Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.

FDA root cause category: Component design/selection

What the company is doing

On 12/5/12, the firm, Brunnell, Inc., issued a public press notification to their consignees. A. On or before 12-12-2012 a certified letter will be sent to all customer listed in the customer database. Specifically each customer will receive two certified letters; one directed to Director of Respiratory Therapy and a second to the Director of Biomedical Engineering. The certified letter will contain a copy of the Recall Noticeand a copy of the Certificate of Medical Necessity. The Certified Letter receipts will be maintained. On the mailing date a copy of the Recall Notice will be placed on the Bunnell website. B. An Excel database will be maintained for each customer/lot #. The database will contain the current status for each. Included will be: 1. Customer Information 2. Date Certified Letter Sent 3. Date receipt received and filed 4. Date product returned or that no stock remains 5. Lot number & Quantity C. On or before 02-01-2013, a second letter will be sent to those customers who have not responded to the original certified letter. D. Data will be maintained in the database E. On or before 04-01-2013, a phone call will be placed to those customers who have not responded to either of the letters. F. Data will be maintained in the database G. On or before 04-15-2013, a second phone call will be placed to those customers who have not responded to the letters or previous phone call. H. Data will be maintained in the database I. On or before 06-07-2013, a Final Recall Notification certified letter will be sent to those customers who have not responded to either of the previous letters or phone calls. J. The Certified Letter receipt will be maintained K. Data will be maintained in the database L. When PMA for alternate heater wire is approved, steps A-K will be repeated. Dates will be determined. M. Following completion of Step L, a final review of the database will occur. Final tabulation of the status for each custo

Recall details

Recall number

Z-0514-2013

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Nov 19, 2012

Posted by the FDA

Dec 14, 2012

Recalling firm

Bunnell, Inc.

Quantity

5743 patient circuits distributed in commerce

Product code

LSZ

FDA submissions

P850064

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Malaysia, and Uruguay (animal study only).

Product description

Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.

Other devices under the same FDA submission

3 devices cleared under P850064 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Bunnell 903

  Bunnell, Incorporated · Ventilator, High Frequency
  1 recall0 reports
• LifePort 2.5 mm

  Bunnell, Incorporated · Ventilator, High Frequency
  1 recall0 reports
• LifePulse 312

  Bunnell, Incorporated · Ventilator, High Frequency
  1 report