MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR52311EU0110

Device Problem Chemical Spillage (2894)

Patient Problems Irritation (1941); Chemical Exposure (2570)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

It was initially reported by company representative that during bathing procedure, disinfectant was leaking into the bath: the resident was in the bath when the caregiver turned on the hydromassage.As soon as the function was initiated a strange, distinct smell arose (staff said it smelled like ammonia).Both the resident and the caregiver's throats and eye began to sting and itch and they found it difficult to breath.The caregiver turned off the hydromassage and emptied the bath.She proceeded by washing the resident 2-3 times with warm soapy water followed by a thorough rinse to avoid any risk of irritation to his skin.The caregiver & resident left the room to get some fresh air.They also aired out the room as quickly as possible as the smell was making it s way out into the hallway.No other information about patient's or caregiver's outcomes were provided.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events system 2000 we have found a low number of other similar cases - disinfectant leaking into the bath.We have been able to establish that there is no complaint trend concerning these kind of events.Please not that arjohuntleigh manufactured over (b)(4) system (b)(4) baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of specification.The device was being used for patient handling and in that way contributed to the event.From received information stinging and itching in caregiver's and resident's eyes and throats (difficulty with breathing) occurred as a result of this incident.In relation to our evaluation we consider events where disinfectant was leaking into the bath and the caregiver or patient were complaining on irritation to eyes or throat to be reportable in the abundance of caution.A test was performed at arjohuntleigh, in relation to this kind of events, and showed that a faulty injector in combination with a malfunctioning non return valve can cause a siphon effect making it possible for disinfectant to leak into the bath.The test also showed that the leakage is highly noticeable by smell.A worst case scenario testing has concluded a maximum mixing ratio of disinfectant that can end up in the bath session with a patient present.This mixing ratio is considered as not being likely to cause any serious injury or death.The review of above information did not show any anomalies.We were not able to establish the exact cause why injector and non-return valve failed.However from above evaluation and internal test regarding use of the disinfection functions, we can conclude that user error cannot be ruled out: not following recommendation of instructions for use: cleaning and disinfecting the tub.Importer ref #(b)(4).

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5, box 61; eslov 2412 1; SW 24121
• 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 ; 2103170412
• MDR Report Key: 4260905
• MDR Text Key: 19401982
• Report Number: 9611530-2014-00088
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/14/2014,10/17/2014

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
• Device Model Number: AR52311EU0110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Distributor Facility Aware Date: 10/17/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/14/2014
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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
• Patient Age: 22 YR