MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB PRIMO FERRO; BATH, HYDRO-MASSAGE

Model Number AS31801GB0000

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2014 that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted (b)(4).Currently arjohuntleigh is in the process of gathering information about possible root cause of the contamination.A follow-up report will be provided as soon as the conclusion of the investigation would become available.

Event Description

Arjohuntleigh has been informed that a primo ferro bath has been tested positive for contamination with pseudomonas aeruginosa.The bath has been taken out of use.No patient 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 (b)(6) 2017 arjohuntleigh was informed by customer (b)(6) that primo ferro (system 2000 product line; serial number: (b)(4)) bathtub located on the ward 37 (burns unit) of the facility was contaminated with significant 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 (including primo ferro) 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.The customer was concerned with pseudomonas aeruginosa contamination of disinfection line.The facility stated that it may have led to immunocompromised patients being exposed to contaminated water.Please note that based on the information received from complainant no injury was observed.According to the information presented by the customer facility, the first signals of contamination on primo ferro bathtub, were reported on 2015-jun-04, when microbiological tests confirmed presence of pseudomonas aeruginosa in the shower attachment.On 2016-jun-14 the bacterium was detected in bathtub disinfection hose and this is the subject of the investigation.This was the first confirmed microbiological test of the primo ferro bathtub disinfection line and the results showed significant level of bacterium in this assembly.Taking into account the period between 2015-jun-04 and 2017-jun-08 over 30 microbiological tests were performed by hospital in parallel with actions aiming to remove presence of the bacteria.Please find the below criteria and related responses, which were established by department of health for england for test results.The performed actions were compliant with the appendix d of health technical memorandum (htm 04-01), which describes the procedures of testing (including results interpretation) for pseudomonas aeruginosa: key - result (per 100ml) - action: p.Auroginosa not detected - not detected - no action.Unsatisfactory - 1-10 cfu - re-test pre/post flush.Significant - >10 cfu - risk assess removing outlet from service, and re-test pre-/post-flush.The significant levels of the pseudomonas aeruginosa were detected on shower attachment, bath outlets and disinfection hose, which were the sampling points.On 2016-aug-30 the facility removed disinfection attachment from the primo ferro due to found excessive bacterium level (samples taken on 2016-aug-11).The facility suspected that disinfection attachment may have been transmitted the bacterium to other bath parts.The re-sampling performed on the shower attachment and bath outlet on 2016-sep-02 (after removal of the disinfections hose) did not detect any contamination.However, during the period from 2016-sep-02 till 2017-may-30 shower attachment was tested 14 times and contamination was confirmed in 5 cases.During the same period, tests of the bath outlets did not detect pseudomonas contamination.As per information provided by customer, after the positive results of samples taken from 2017-may-30, the full maintenance procedure recommended by arjohuntleigh was carried out.The last microbiological results provided to arjohuntleigh representative referred to tests done on 2017-jun-08.It confirmed the effectiveness of the shower attachment decontamination as bacterium was not detected.Based on the information provided within the complaint we are able to state that in order to decrease the pseudomonas aeruginosa contamination facility introduced procedures including: parts replacements (i.E.Mixer cartridges or shower hoses), thermal disinfection or pasteurization of internal bath pipework, mixing unit (submersion in 90 celsius degrees water for 40 minutes) and all outlets (shower/bath/disinfection at 60 celsius degrees for 15 minutes each), chlorination of the new disinfection and shower hoses before installation.In reference to the recommendations described in the operating and product care instructions [04.Ar.09_9gb] 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.According to 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 primo ferro (system 2000 line) was contaminated with bacteria.It should be underlined that this bathtub was manufactured in 2009 and due to long period of usage, during which device was exposed to various environmental factors, the manufacturing process was excluded as a source of contamination with pseudomonas aeruginosa bacteria.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: PRIMO FERRO
• 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: 6739443
• MDR Text Key: 80907449
• Report Number: 3007420694-2017-00163
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,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: AS31801GB0000
• 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: 07/03/2017
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 10/31/2017; 11/30/2017
• Date Device Manufactured: 07/01/2009
• 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