MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 UNKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problems Fire (1245); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.

Event Description

Material no.: unknown.Batch no.: unknown.It was reported by the health professional suspected substance or medicinal product missing.Per email: please note that the ema obtained this reference and discarded it based on 4.5 - suspected substance or medicinal product missing.Per final cioms: the surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.

Manufacturer Narrative

Initially reported "it was reported by the health professional suspected substance or medicinal product missing." further information was provided on the case " he surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.Bd was unable to perform a thorough investigation as no sample, were provided.Possible potential causes include: solution is combined with ignition source.Current controls include user instructions and safety instructions that indicate that allowing solution to pool is contraindicated for safety multiple warning labels regarding flammability and use with ignition sources.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Type of event was updated on supplemental mdr from malfunction to serious injury.

Event Description

Material no.: unknown batch no.: unknown.It was reported by the health professional suspected substance or medicinal product missing.Per email: please note that the ema obtained this reference and discarded it based on 4.5 - suspected substance or medicinal product missing.Per final cioms: the surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.

• Brand Name: UNKNOWN CHLORAPREP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 11877959
• MDR Text Key: 255514448
• Report Number: 3004932373-2021-00259
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR