MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR33212-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Caustic/Chemical Burns (2549)

Event Type  Injury  

Event Description

It was initially reported by company representative that during the process of cleaning the bath, a splash of the chemical came in contact with the employee's eye.No ppe's were used or available in the room.Additionally, the employee who was cleaning the arjo tub was unaware of the proper procedures to use the auto dispenser for the disinfectant iv (used disinfectant).The tub was brought to up to allow for ergonomic cleaning.Disinfectant iv was used in its undiluted form to clean the tub.From received information chemical burn occurred to the caregiver due to suspected exposure of undiluted chemical to the eye.Involved caregiver was admitted to the emergency room, and an extensive eye flushing procedure was administered.No further outcomes occurred.

Manufacturer Narrative

(b)(4).Device examination described in incident description form (idf) showed that general condition of the bath was good.Involved bath was fully functional, no faults were found - device met its specification.Arjohuntleigh representative informed also in idf about possible cause of this incident: "i was informed that the employee did not have proper training to know how to properly use the auto dispenser." no information about last training was provided as well.New training is in the process of being scheduled with clinical consultant locally.When reviewing similar reportable events for system 2000 we have found a low number of other similar cases-splash of disinfectant onto the caregiver.We have been able to establish that there is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured over (b)(4) baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification.The device was being used for patient handling and in that way contributed to the event.From received information chemical burn occurred to the caregiver due to suspected exposure of undiluted chemical to the eye.Involved caregiver was admitted to the emergency room, and an extensive eye flushing procedure was administered.No further outcomes occurred.We have not been able to find any contributing manufacturing anomalies.Received information showed that the caregiver was not wearing goggles during disinfection procedure.No ppe (personal protective equipment) was available in the room.Arjohuntleigh representative informed also that the employee did not have proper training to know how to properly use the auto dispenser.The splash is not likely to be caused by device itself and these kind of events are considered to be unfortunate accidents.There are also other factors that need to appear to cause this incident e.G.: lack of carefulness, incorrect process of disinfection.Therefore, we consider this event to be isolated incident where user wasn't care enough to avoid this incident.From above we can conclude that this problem was caused by user error: incorrect use of the product: no safety equipment used during disinfection of the device.Incorrectly trained staff: lack of training regarding use and maintenance of the device.The received information and our evaluation as described above are showing that if system 2000's warnings were followed in accordance to instruction for use, there would be no patient or caregiver at risk.Impref# (b)(4).

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5, box 61; eslov ; SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5, box 61; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4076789
• MDR Text Key: 4895602
• Report Number: 9611530-2014-00054
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/05/2014,07/10/2014

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: Health Professional
• Device Model Number: AR33212-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2014
• Distributor Facility Aware Date: 07/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2014
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other