MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EMEA CIDEX® OPA SOLUTION; BIOCIDES SOLUTION

Catalog Number 20391

Device Problems Device Rinsing Issue (2309); Chemical Problem (2893); Environmental Compatibility Problem (2929); Improper Chemical Reaction (2952); Ventilation Problem in Device Environment (3027)

Patient Problems Respiratory Distress (2045); No Code Available (3191)

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a female health care worker (hcw) developed symptoms of coughing, shortness of breath, and difficult breathing while manually processing endoscopes with cidex ® opa solution.Her symptoms occurred after working around cidex ® opa solution for some time.The hcw went to the emergency room (er) on (b)(6) 2017 where she was treated with ¿inhalation¿ therapy and it was reported her symptoms lasted ¿some hours¿.A diagnosis of ¿chemical pneumonitis¿ was made in the er.The hcw was prescribed these inhalers: ¿salbutamol, prednisolone, beclometasone¿, and currently takes these medications.The hcw was ¿incapacitated for a week¿ but returned to work and continues to work around cidex ® opa solution.It was reported the hcw still has symptoms of coughing.It is reported the hcw has no history of asthma or respiratory conditions and no known allergies.The hcw had an appointment with pulmonology on (b)(4) 2017 and remains ¿in treatment¿ with the previously prescribed inhalers, but no further details are known.No allergy skin testing has been done for cidex ® opa solution, and there has been no diagnosis of ¿occupational asthma¿ made.An international search for the three inhalation medications was performed on the world health organization (who) website: who 20th essential medicine list ( (b)(6) 2017).Both salbutamol and beclometasone are listed as anti-asthmatic inhalation medications; however, prednisolone is not recognized as an inhalation medication.Regarding the room where cidex ® opa solution is used, it was reported the room did not have ventilation and does not have air exchanges.It was however, noted, a ceiling fan was installed before this event occurred.The hcw was reported to wear personal protective equipment (ppe) while handling cidex ® opa solution, however, the type of ppe is unknown.Regarding the manual cleaning process with cidex ® opa solution, it was reported the customer uses trays with tight-fitting lids between uses, however, they are not advanced sterilization products (asp) trays.Per cidex ® opa solution instructions for use (ifu) precautions, it states ¿use cidex ® opa solution in a well-ventilated area and in closed containers with tight-fitting lids.If adequate ventilation is not provided by the existing air conditioning 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.¿ at this hospital, it was confirmed they do not have local exhaust hoods or ductless fume hoods/portable ventilation devices as instructed in the cidex opa ifu.The asp sales representative has scheduled training to review the ifu.Regarding the cidex opa rinsing process, it was reported the hcw rinsed with running water (about 5 liters) for three minutes.Per cidex opa ifu: ¿keep the device totally immersed for a minimum of 1 minute in duration¿ and ¿three (3) separate, large volume water immersion rinses are required.¿ in this event, there were no reports of patients affected from improperly rinsed devices, however, it was confirmed these devices were not rinsed per cidex opa ifu and used on patients.The asp sales representative has scheduled re-training for this customer.Based on the information contained in the complaint at the time the reporting determination was made, this complaint is deemed reportable as a serious injury.Although it was reported the room was not ventilated and the hcw has not been diagnosed with occupational asthma, the hcw experienced respiratory reactions and was diagnosed with ¿chemical pneumonitis¿ when using cidex ® opa solution and received medical intervention in the er.In addition, the hcw is taking prescription medications to treat her symptoms.Lastly, unrelated to the hcw symptoms, the (b)(4) affiliate confirmed there was patient contact with a medical instrument that was not rinsed per cidex ® opa solution ifu; therefore, as a matter of policy, this event is also being reported as a malfunction.

Manufacturer Narrative

The investigation included a review of the device history record, complaint trending, and system risk analysis (sra).The device history record could not be reviewed as the lot number was not available.Complaint trending could not be performed as the lot number was not available.The sra for the reported device rinsing issue indicates the risk associated with exposure to toxic or corrosive material is "low." the sra for the reported respiratory issue indicates the risk associated with exposure to toxic or corrosive material is "low." visual analysis was not performed as the product was not returned for evaluation.The supplier was not notified of the issue as the issue was not identified as a manufacturing or functional issue.The likely assignable cause of the human reaction respiratory issue was likely due to poor ventilation in the processing room.The likely assignable cause of the device rinsing issue was due to user error and not following the instructions for use (ifu).Customer re-training was performed to review the cidex opa solution ifu for proper room ventilation and adequate rinsing.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: EMEA CIDEX® OPA SOLUTION
• Type of Device: BIOCIDES SOLUTION
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7069546
• MDR Text Key: 93285852
• Report Number: 2084725-2017-00664
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K991487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1