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

Model Number AP31801-GB

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh has been informed that a system 2000 bath has been tested (b)(6) for contamination with pseudomonas.The bath has been taken out of use.No patient was involved.

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.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 2017-aug-23 arjohuntleigh has been informed by customer (b)(6) (facility management partner) that based on the results of microbiological tests of arjohuntlegh system 2000 bathtub (serial number (b)(4)) located in (b)(6) hospital ((b)(6)) it is contaminated with excessive levels of pseudomonas aeruginosa bacteria.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 spreaded by equipment that gets contaminated and is not properly cleaned and maintained.On 2017-aug-23 an arjohuntleigh representative was informed about the microbiological tests performed in (b)(6) hospital on the system 2000 bathtub, which revealed excessive levels of pseudomonas aeruginosa bacterium.According to this information the samples for tests were taken on (b)(6) 2017 from the bathtub (b)(4) located on the ward (b)(6) hospital and were examined by external laboratory services provider.On 2017-jun-20 the facility was informed that the results of tests were positive with pseudomonas bacteria levels of >100 cfu/100ml pre flush and 8 cfu/100ml post flush.The parts of the bathtub from which the samples were obtained remain unknown.The laboratory carried out chlorination on the shower installation of the bathtub to decrease the contamination.No further test results for this bathtub were provided by customer.On 2017-aug-24 the arjohuntleigh received a request from (b)(6) regarding removal of the shower attachment (handle and hose) from the bathtub (b)(4) as a result of bacterium remaining in this part.The customer removed disinfection handle and hose on its own earlier as per recommendation of the internal facility microbiologist consultant.The shower attachment was removed from the bathtub and device was used without the showering function despite that this solution was not approved by arjohuntleigh.The customer was informed by arjohuntleigh representative that this kind of modification is not authorized and may impact the product performance.Please note that according to recommendations described in the operating and product care instructions (04.Ar.07_7gb) 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.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 2006 therefore the manufacturing process cannot be considered as source of contamination with pseudomonas aeruginosa due to long time in use during which device was exposed to various environmental factors.Moreover, it was confirmed that bacterium was found in other points of the facility, which were not adjacent to the arjohuntleigh bathtub.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.Therefore this type of event will no longer be seen as a reportable complaint.

• 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 ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6841383
• MDR Text Key: 86576084
• Report Number: 3007420694-2017-00185
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2017

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: AP31801-GB
• 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: 11/27/2017
• Distributor Facility Aware Date: 08/23/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2017
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 11/27/2017
• Supplement Dates FDA Received: 10/31/2017; 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/25/2006
• 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