MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AP31800GB1000

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has been informed that a system 2000 bath has been tested (b)(6) for contamination with pseudomonas.Currently arjohuntleigh is in the process of gathering information about possible root cause of the contamination.

Manufacturer Narrative

Arjohuntleigh is still in the process of gathering more information regarding the issue.The investigation has been planned by different sites of the company to clarify the customer's allegation.Additional information will be provided no later than 25th july 2017.

Manufacturer Narrative

Arjohuntleigh have acknowledged that pseudomonas aeruginosa is extremely common bacteria that is present in moist environments such as soil, water, sinks and showers and often found in spas or purified water system operators.Pseudomonas grows in water and thrives at warm temperatures.It grows quickest if the water is allowed to sit without movement.At this time we are not able to confirm the source of the bacteria reported.This is the subject of the investigation that is still ongoing.A follow-up report will be provided as soon as the conclusion of the investigation would become available.

Manufacturer Narrative

The investigation including analysis of potential sources of contamination allowed to exclude the manufacturing process as the source of bacteria.The results of microbiological test performed on swabs taken from cold, hot inlets, tap and filter were negative (presumptive pseudomonas unconfirmed).The test of the water supply use during manufacture's quality control process did not reveal any presence of bacteria.Further investigation is ongoing.A follow-up report will be provided as soon as the conclusion of the investigation would become available.

Manufacturer Narrative

On (b)(6) 2017 arjohuntleigh has been informed by customer (b)(6) that based on the results of microbiological tests of arjohuntlegh system 2000 bathtub (serial number (b)(4)) located in facility's oncology ward it is contaminated with excessive levels of pseudomonas aeruginosa bacteria (no specific values was provided).No adverse event or injury was reported.The review of similar reportable events with the involvement of the system 2000 baths in last 5 years, revealed a low number of cases where it was indicated that the bath was contaminated with the pseudomonas aeruginosa bacteria.The occurrence rate observed for this failure mode is considered to be low.Please note that pseudomonas aeruginosa is a common environmental organism and can be found in faeces, soil, water and sewage.It can multiply in water environments and also on the surface of suitable organic materials in contact with water.It can be spread by equipment that gets contaminated and is not properly cleaned and maintained.Based on the information received from arjohuntleigh representative on 2017-apr-04 the contaminated bathtub was removed from service according to the customer facility internal procedures.In order to exclude a potential source of contamination, on 2017-may-08 the facility decided to remove the water supply installation hoses (made of plastic) installed inside the false wall and replaced them with metal pipes (made of copper) as customer suspected it may decrease a contamination.A few days later (on 2017-may-11), another microbiological test was performed.Based on the results received, piping replacement did not remove the bacterium.The further investigation was conducted towards the second set of hoses (connecting false wall water installation with bathtub).These hoses were also replaced with new parts (made of plastic), which were chlorined prior to installation.On 2017-may-25 the external laboratory services provider took samples from the following spots: feedwater installation (from the flex hoses before they were replaced) including hot and cold inlets, both pre and post flush (after 2 minutes); bath tap (hot and cold; pre and post flush); bath shower (hot and cold; pre and post flush); tap from sink in room (blending tap: hot and cold; pre and post flush).After results analysis it was noticed, that only samples taken from the bathtub shower handle were found to be contaminated with pseudomonas aeruginosa (>100 cfu/100ml).The previously removed flexible hoses (connecting false wall water installation with bathtub) were microbiologically tested by an external laboratory.The results showed that one of them was bacteria-free and the second had pseudomonas aeruginosa level of 1 cfu/100 ml.The laboratory was not able to determine which of them was formerly connected to hot and which to cold water supply.According to recommendations described in the operating and product care instructions [04.Ar.08_8gb] which was delivered with this device, the bath should be disinfected immediately after every use and every day.Moreover, it states that user of the bathtub is obligated to remove and clean strainers in the shower heads on monthly basis.Based on the microbiological formation prevention bulletin [08.Ar.05_1gb], in order to limit the growth of bacterial flora, it is necessary to take action at four levels: avoid stagnating water and make sure proper water circulation; take precautions against the formation of scale and corrosion based on the water quality; maintain a high water temperature all the way from the hot water dispenser to the different distribution pipes; mix hot and cold water as close as possible to the point of use.In summary, the complaint was decided to be reportable based on the allegation that arjohuntleigh bath system 2000 was contaminated with bacteria.It should be underlined that this bathtub was manufactured in 2009 and due to long period of bath usage during which device was exposed to various environmental factors, the manufacturing process was excluded as a source of contamination with pseudomonas aeruginosa bacteria.As per results of laboratory microbiological tests the bacteria was found in water hose, which was mounted before installation of the arjohuntleigh bathtub hydraulic system.The results of the investigation performed enable us to determine that allegation reported does not compromise patient safety and is not likely to cause or contribute to a death, serious injury or deterioration in the state of health.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6529521
• MDR Text Key: 74152273
• Report Number: 3007420694-2017-00100
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2017

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: No Information
• Device Model Number: AP31800GB1000
• 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: 11/30/2017
• Distributor Facility Aware Date: 04/04/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: Not provided; 04/04/2017; 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 05/26/2017; 07/18/2017; 10/31/2017; 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2009
• 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