MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP Z O.O SYSTEM 2000; BATH, SITZ, POWERED

Device Problem Chemical Spillage (2894)

Patient Problems Skin Irritation (2076); No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

On 2017-dec-21 arjohuntleigh was informed that during the disinfection of system 2000 bathtub the customer facility personal support worker was exposed to the undiluted arjoclean iv disinfectant, which came in contact with her skin (above the glove, in the elbow area).The psw was changing the disinfectant bottle, when some of the disinfectant sprayed out of the bottle as it was placed in the reservoir of the tub.The customer facility personal support worker sustained a skin irritation on right arm.Based on the information provided, the person injured was not objected to any medical intervention and performed a self care of the irritated area.The event occurred approximately 1.5 years ago (exact date was not available), but was not reported to arjohuntleigh to date.

Manufacturer Narrative

On 2017-dec-21 arjohuntleigh was informed that during the disinfection of the system 2000 bathtub the customer facility employee (personal support worker) was exposed to the undiluted arjo disinfectant cleanser iv, which came in contact with her skin (above the glove, in the elbow area).The employee was changing the disinfectant bottle (with the cap off the bottle), when some of the disinfectant sprayed out of the bottle during placing the container in the reservoir of the tub.According to the obtained information, the employee opened the bottle of disinfectant by removing the seal completely, left the cap off the open bottle and then placed in the reservoir.Therefore the movement caused the disinfectant to spray out the bottle where the cap would normally be placed.The employee sustained a skin irritation on right arm due to contact with disinfectant.Based on the information provided, the injured caregiver was not subjected to any medical intervention but performed a self-care of the irritated area.Please note that according to the customer the event occurred approximately 1.5 years ago (exact date not provided by facility representative), but was not reported to arjohuntleigh to date.According to the provided information the involved system 2000 bathtub was replaced and the disinfection system was already new when customer notified arjohuntleigh.The disinfectant liquid has been changed many times since this incident occurred.Therefore neither the serial number of involved bathtub nor batch number of disinfectant container was made available.The review of similar reportable events with the involvement of the system 2000 baths or arjo disinfectant cleanser iv in last 5 years, revealed a low number of cases where it was indicated that caregiver sustained skin injury due to contact with disinfectant liquid.The arjo disinfectant cleanser iv is a liquid intended to clean and disinfect medical device equipment within the arjohuntleigh healthcare solution product range.This disinfectant is available only for (b)(6) market and as per system 2000 ifu is one of the recommended disinfectant liquids for this device.Due to fact that manufacturing dates of the bathtub were not provided by customer the most recent revision of instructions for use (id 04.Ar.12_11gb issued in january 2017) was used in this investigation.Please note that system 2000 ifu include guidelines for proper disinfection handling: "to avoid eye and skin damage, always use protective glasses and gloves.If contact occurs rinse with plenty of water.If eyes or skin becomes irritated, contact a physician.Always read the material safety data sheet of the disinfectant." based on the information provided by facility representative the involved personal support worker did not look for medical attention.As stated above the ifu warns that if skin or eyes become irritated, the user should rinse affected area with extensive amounts of water and consult a physician.The involved user performed some kind of self-care, but the specific procedure remains unknown as well as severity of the alleged injury.The disinfectant safety data sheet (mentioned in system 2000 ifu), in section precautionary statements provides the warning related to procedure to follow when exposure occurs: "if on skin (or hair): remove immediately all contaminated clothing.Rinse skin with water.Wash contaminated clothes before reuse." moreover, the disinfectant safety data sheet in section exposure controls/ppe advises the following: "handle in accordance with good industrial hygiene and safety practices.Provide suitable facilities for quick drenching or flushing of the eyes and body in case of contact or splash hazard." warnings regarding risks of improper use of the disinfectant are also available on the disinfectant container label together with procedure to be followed in case of exposure to liquid: "first-aid: in case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes." system 2000 ifu provides the procedure for replacement of disinfectant bottle (for baths with disinfection option only) which should be followed by every device user who attempts to change the disinfectant liquid container.Based on the event description the replacement was not correctly carried out as a bottle with disinfectant was placed in the bathtub reservoir with removed cap and punctured seal.At this time as the container was opened and unsealed it caused that some liquid sprayed off the container.As an action after the event the involved customer facility employee was trained of the bath disinfection procedure including personal protective equipment use, safe positioning of the disinfectant liquid container and of the product ifu content.In summary, although no adverse event occurred the complaint was decided to be reportable as the caregiver was exposed to undiluted disinfectant and in consequence sustained skin irritation.The event occurred during disinfection procedure and no patient was involved.According to the information collected during investigation the involved bathtub met its manufcturer's specification.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, SITZ, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• MDR Report Key: 7152552
• MDR Text Key: 96119344
• Report Number: 3007420694-2017-00235
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

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: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Distributor Facility Aware Date: 12/21/2017
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other