MAUDE Adverse Event Report: TELEFLEX HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONGAT; NON-REBREATHING MASK

Catalog Number 1059

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 12/06/2013

Event Type  Death  

Event Description

The event is reported via a medwatch.The customer describes the event in the medwatch as: the patient first had a removal of temporary pacemaker leads and removal of a temporary dialysis cath on the left side.An hour after, the patient was prepped on the left side for placement of a permanent pacemaker.Chloraprep 10.5ml used on the right side, chloraprep 26ml used on the left side.After prepping with chloraprep, scrub tech laid the surgical towels on the shoulder and went to scrub and get a lead apron.Ten to fifteen minutes later the tech continued with the rest of the sterile field and layout of 3m ioban 2 surgical drape.Placed pacemaker drape and towels.The nurse set up the oxygen supply at 15lpm non-rebreathing mask with the bag towards the head instead of the feet to clear space for the sterile field for the procedure.The esu return pad was applied to the right thigh and connected it to the esu generator.The esu was set to 35 watts in cut and coag modes.The esu pencil was connected and placed in the holster in the surgical field.The esu generator set for use in monopolar mode.After the physician scrubbed and gowned, the surgical curtain was hung over the holder.The physician injected approx.20cc of lidocaine cocktail and made three incisions.Picked up the esu pencil to control some bleeders.Activated the pencil by pressing the button in the pencil's handle.Spark flash from his pencil's tip toward the sterile field and up to the patient's chin area.Within a second flash fire occurred through the surgical towels and the 3m ioban 2 surgical drape.Flames shot out of the mask's tubing and burst the face mask bag.Fire noted around the patient's face mask and hair.Set up of burning surgical drape was removed and stomped out while the nurse turned the oxygen source off.Fire took 10-15 seconds to extinguish.Fire resulted in thermal burns to face and neck.Patient intubated to protect the airway and transferred to a burn center.Date of event - (b)(6) 2013.Date of death - (b)(6) 2013.Cause of death - congestive heart failure complicated by thermal injuries (as reported in the medwatch).

Manufacturer Narrative

A phone discussion was conducted with (b)(4)(risk manager at the user facility) and (b)(4)(ra clinical specialist, teleflex).(b)(6) reports that a medwatch was submitted to teleflex as a notification that a teleflex device, a hudson non-rebreathing mask (catalog number 1059) was in use at the time of the reported event.(b)(6) also indicates that the hudson non-rebreathing mask did not malfunction during the reported event.The mask was involved in the fire triangle (oxygen, heat and fuel).Evaluation: a visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided for evaluation.The lot number was not provided, therefore, it is not possible to determine in which conditions this material was manufactured.Accordingly, it is not possible to investigate this matter further.According to complaint description the mask was in use at the time of this incident but was not the cause of the event.This information was reported by the risk manager of the user facility.If the sample or a picture of it becomes available this investigation will be updated.

• Brand Name: HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONGAT
• Type of Device: NON-REBREATHING MASK
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3754219
• MDR Text Key: 4469010
• Report Number: 3004365956-2014-00143
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• 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: Initial
• Patient Sequence Number: 1
• Treatment: BOVIE: E2515H, MANUFACTURER COVIDIEN; MANUFACTURER: 3M CORP.; CHLORAPREP WITH TINT: MANUFACTURER CAREFUSION; HUDSON NON-REBREATHING MASK: CATALOG #1059; 3M IOBAN ANTIMICROBAL INCISE DRAPE E25B; MANUFACTURER: TELEFLEX MEDICAL; ELECTRODE: (B)(4), MANUFACTURER CONMED
• Patient Outcome(s): Death
• Patient Weight: 102