MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EMEA CIDEX® OPA SOLUTION; BIOCIDES SOLUTIONS (MED)

Catalog Number 20391

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problems Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943); Nausea (1970); Red Eye(s) (2038); Respiratory Distress (2045); Skin Irritation (2076); Swelling (2091); Tachycardia (2095); Vomiting (2144); Dizziness (2194); Anxiety (2328); No Code Available (3191)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An international customer reported a healthcare (hcw) experienced ¿nausea, dizziness, pressure drop, vomiting, irritated red eyes and face¿ while working manually reprocessing instruments using cidex® opa solution.Advanced sterilization products (asp) requested and received additional information regarding this event.The hcw has worked around cidex® opa solution for two months.The room where the hcw was working is small and not well ventilated.Air exchanges have not been measured.The hcw was wearing a 3m disposable respirator, goggles, disposable apron, and rubber glove over apron.Although the hcw was wearing personal protective equipment, on (b)(6) 2018, the hcw developed symptoms after she had been working in the poorly ventilated room for four hours and then she opened a new bottle of cidex® opa solution.The solution splashed on her skin and she also inhaled the vapors in the small work space.Her symptoms and duration were reported as follows: nausea - lasted approximately 10 minutes.Vomiting ¿ it was reported the hcw had ¿normal meals¿, and symptoms occurred immediately after opening the new bottle and lasted approximately 2 minutes.Dizziness - occurred immediately after opening the new bottle and lasted approximately 5 minutes.Shortness of breath ¿ occurred immediately after opening the new bottle and lasted approximately 3 minutes.Difficulty breathing with blue lips ¿ lasted approximately 3 minutes.(however, it was noted there was no wheezing, no bronchospasms, and no chest tightness).Swelling of the mouth, tongue, lips, vocal cords ¿ lasted 2 minutes.Nasal congestion ¿ occurred immediately after opening the new bottle and lasted approximately 10 minutes.Hoarseness ¿ occurred after working approximately 4 hours in the reprocessing room and lasted approximately 10 minutes.Coughing - occurred immediately after opening the new bottle and lasted approximately 2 minutes.Hypotension / blood pressure: 90 systolic/50 diastolic ¿ lasted approximately 2 hours.Tachycardia / pulse 115 ¿ lasted approximately 30 minutes.Anxiety ¿ lasted approximately 10 minutes.After the event occurred, the hcw washed her face with water and was seen in the emergency room.She was treated with saline solution 0.9% intravenously (iv) for hypotension; however, no medication was given, and no other medical intervention was reported, including no oxygen, no steroids, and no breathing treatment.There was no diagnosis (including no anaphylaxis), the hcw has no known allergies, and no allergy skin testing was done.It was reported the hcw recovered on the same day of the event and she is ¿well¿.She continues to work around cidex® opa solution and has had no further symptoms.It was also reported there are other hcw¿s that work in this small, poorly ventilated room, but none have experienced any symptoms.An advanced sterilization products (asp) clinical account leader visited the hospital and instructed the hcw and other staff in the department on proper use of cidex opa according to the instructions for use (ifu), including this section under ¿precautions¿: ¿use cidex opa solution in a dedicated room with adequate ventilation and in closed containers with tight-fitting lids.Please reference local/state/country requirements for appropriate number of air exchanges per hour.If adequate ventilation is not provided by the existing air handling system, use in local exhaust hoods, or in ductless fume hoods/portable ventilation devices which contain filter media which absorb ortho-phthalaldehyde from the air.¿ based on the information contained in the complaint at the time the reporting determination was made and out of an abundance of caution, this event is deemed reportable.Although the hcw experienced skin and eye, respiratory, neurologic, and gastro-intestinal symptoms which resolved quickly without medication and further intervention, she was treated for cardiac symptoms of hypotension with iv fluid therapy.Furthermore, there was no reported malfunction with cidex® opa solution, but the hcw was not following the cidex® opa solution ifu and she was working in a small room with poor ventilation, where air exchanges have not been measured.

Manufacturer Narrative

Additional follow-up with the customer confirmed the healthcare worker was wearing a 3m vapor respirator, model # 8822 while working in the reprocessing room.There were 4 bottles of cidex opa solution used in the room at the time of the event.Asp complaint ref #: (b)(4).

Manufacturer Narrative

The investigation included a review of the batch history record, complaint trending by lot number, and system risk analysis.The batch history record was reviewed and the test specifications for product release were met.No issues were observed that could contribute to the complaint.Trending analysis by lot number was reviewed for the previous six months no significant trend was observed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the likely assignable cause of the issue was likely due to poor ventilation in the room and the use of respirator mask that does not prevent the inhalation of vapor.The customer was advised to use cidex opa solution in a dedicated room with adequate ventilation and in closed containers with tight lids.A customer letter was sent with the instructions for use (ifu) and precautions for proper ventilation and use of a vapor mask.The issue will continue to be tracked and trended.(b)(4).

• Brand Name: EMEA CIDEX® OPA SOLUTION
• Type of Device: BIOCIDES SOLUTIONS (MED)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7931486
• MDR Text Key: 122545962
• Report Number: 2084725-2018-00718
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 20391
• Device Lot Number: 260218/050
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR