MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX XTRAFLOW HME; HEAT AND MOISTURE EXCHANGER

Catalog Number 7290

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/27/2016

Event Type  Injury  

Manufacturer Narrative

According to the provided information we know that the patient has used a number of products and has had hypersensitive reactions at least twice.It is not fully determined which product has caused the reaction since the initial reporter stated "provox hme", out of which there are several variants.The initial reporter suggested that the filter inside the hme caused the reaction and this was confirmed in a patch test.We argue that the filter is not in direct skin contact during use and that a patch test is not representative for the component.No product is returned.Further, and possibly more important, it is not clear to us which adhesives and cleaning products have been used at the time of the reactions.It is more likely that one of these would cause irritation to the skin, although the patch test performed showed negative result.We have tried several times to obtain more information in order to understand and perform a more specific investigation - but so far without success.

Event Description

This is the information that was received from the reporting dermatologist: patient had been using a provox hme filter (with the provox adhesive base) for her tracheostomy for over 10 years without any problems.Around easter 2016 she went to get a repeat prescription and the pharmacist advised her that the code number has changed, the only change she had noted was that the color had changed from white to beige.Soon after this she started to develop an eczematous reaction around the stoma site with chronic inflammation and recurrent infections and developed a contracture of the stoma site which required a surgical intervention to correct.

Manufacturer Narrative

E2018017.Atos medical ab (manufacturer, registration no (b)(4)) is submitting the report on behalf of atos medical, inc.(importer, registration no (b)(4)).Evaluation: no product has been returned for technical examination.Lot numbers are unknown.The only information we have received is that one of provox xtramoist hme or provox xtraflow hme were suspected of causing an eczematous reaction.As these products are never used alone but must be attached by an adhesive we have included the two adhesives used in the patients patch test (optiderm and flexiderm) as well.Below is based on clinical evaluation reports, material data and history of sales as well as complaints.Materials and intended use the provox xtramoist and xtraflow are intended for patients breathing through a tracheostoma.They are variants of a heat and moisture exchanger (hme) that conditions inhaled air by retaining heat and moist from exhaled air in the device.It is a single use device in indirect contact via inhaled air with a max usage of 24 hours.The materials used in the provox xtramoist and xtraflow cassettes are as follows: housing: polypropylene (pp).Lid: polypropylene (pp) with beige polyethylene (pe) master batch.Foam: reticulated polyurethane (pur) with calcium chloride (cacl2).The materials included in the products have been tested for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, implantation, and genotoxicity in conjunction with another polypropylene polymer.The materials included are selected for their safe profiles and their suitability for the intended purpose.The plastic material, a polypropylene polymer (pp), is medical grade and cleared through extensive biocompatibility testing by the supplier.The master batch is also medical grade and extensively challenged in supplier tests and internal biocompatibility tests combined with a polypropylene polymer.The hme media (foams) are also extensively tested with regards to biocompatibility and have been used for many years in this application.Provox adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma.The adhesives are attached to the skin around the stoma in order to provide an airtight attachment of components of the provox hme system, e.G.Provox hmes.The adhesives have an adhesive part, a peel-off liner and an adapter where components of the hme system can be connected.The materials included are selected for their safe profiles and their suitability for the intended purpose.The adapter is not in direct contact with the tissue around the stoma.The adapter-material has usp class vi certificate and an additional test of systemic toxicity and sensitization showed that the adapter is not harmful for the patient.The adhesive part is made of hypo-allergenic materials of different types: flexiderm is a very flexible material and has the strongest adhesive properties.It is a sticky, yet soft and flexible adhesive.Raw materials are: ethylene-butylacrylate (eba), polyethylene (pe) and acrylic adhesive.It has been tested for cytotoxicity, sensitization and intracutaneous reactivity by the supplier.Raw materials of optiderm are: ethylene-butylacrylate (eba), hydrocolloid, polyethylene (pe) and acrylic adhesive.The hydrocolloid material of the optiderm adhesives is a substance that forms a gel with water.It has been tested for cytotoxicity, sensitization and intracutaneous reactivity by the supplier.There is extensive data supporting the safety and benefit of using an hme.The lack of reported adverse events related to the included materials, combined with the careful selection of raw materials, there is a firm basis for considering the selected materials to be safe from a biocompatibility perspective.The benefit clearly outweighs the risk.Sold items and reported skin reaction or irritation during the period 01/01/2016 until 04/30/2018 is included below.(b)(4) flexiderm was sold, with 2 reported cases of skin reactions (including the current one).(b)(4) optiderm was sold, with 0 reported cases of skin reactions.(b)(4) xtrahme was sold, with 0 reported cases of skin reactions.Changes: there were no material changes made to either product during the time before or around easter 2016, when the skin reaction presented itself.Discussion: the hme media is reticulated polyurethane foam and has been throughout provox hme generations.The media is not in skin contact during use of the device and the cacl2 may be the cause of a positive response to a patch test without causing reaction during use.A more probable cause for the eczema would be sensitivity to chemicals in the adhesives or accessories to these, such as additional glue or cleansing wipes.A strong adhesion will also mechanically irritate the skin.The ifu for the adhesives includes a warning to discontinue use and seek medical advice in case of skin irritation.Since no material changes were made and we have no information of batch numbers we have no possibility to investigate this further.Decision: considering the chemical composition of the materials, the type of tissue contact, the performed preclinical biological safety tests and extensive clinical records with very few events related to biological safety concerns, we find that no further corrective or preventive actions are needed.

Event Description

See initial report.

• Brand Name: PROVOX XTRAFLOW HME
• Type of Device: HEAT AND MOISTURE EXCHANGER
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 7468160
• MDR Text Key: 106721997
• Report Number: 8032044-2018-00001
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 07331791005893
• UDI-Public: 7331791005893
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2018
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention