MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MALIBU; BATH, HYDRO-MASSAGE

Model Number AZL33116-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 conclusion of the manufacturer's investigation.

Event Description

Arjohuntleigh has received information about 5 malibu bath systems affected by bacteria pseudomonas aeruginosa.These allegations were limited to one customer: (b)(6) and it has been suggested that arjohuntleigh baths could have been the root cause of the contamination.Currently arjohuntleigh is in the process of gathering proofs whether the allegation originated by this particular customer could be confirmed.

Manufacturer Narrative

This report is being filed under exemption (b)(4) by arjohuntleigh polska sp.Z o.O.(registration#3007420694) on behalf of the importer (b)(4) (registration#1419652).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 22nd july 2017.

Manufacturer Narrative

An investigation was carried out into this complaint.Arjohuntleigh received information about 5 complaints raised by one particular customer facility (b)(6)).Following the information provided by company freeston water treatment (which was providing a water test results for ((b)(6) facility), a (b)(6) bacteria was found in five arjohuntleigh malibu baths in two (b)(6) facilities: (b)(6) (nursing home in (b)(6)) and (b)(6) (nursing home in (b)(6)).The baths in question were installed within 2 weeks before test for bacteria presence was conducted.This report concerns malibu bath with model number azr33116-gb and serial number (b)(4), located in (b)(6) nursing home.It was not revealed to us whether the system has already been used, or not.As a precautionary measure, the customer has taken the baths out of use and disconnected them from the water supplies to minimize possible risk of contamination to the water supply system.No injury was reported as a result of alleged contamination.When reviewing similar reportable events with the involvement of the malibu baths, it was possible to determine a low number of cases where it was indicated that the internal plumbing of the bath was contaminated.The occurrence rate observed for this failure mode is currently considered to be low.(b)(6) 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.From the information collected during the investigation we were able to establish that the (b)(6) was found in the cold water inlet (part of the customer's water installation, supplying water to the bath).It is independent from the bath plumbing system, and its maintenance is under responsibility of the customer.Contamination was caused by using a long runs of pipework in the cold water supply that is being allowed to warm up over a period of time, thus allowing pseudomonas aeruginosa to develop.This source of contamination seems to be a most possible root cause of the bacteria occurrence in the bath.Please be aware that the device owner, who was provided with microbiological formation prevention procedure (included in the instructions for use 04.Az.00_12gb dated on january 2015, which was delivered with the device) is obligated to: make sure that the water circulates in the bath and the shower on a daily basis even if the bathtub is not used; and particular to make sure to remove any water that may be left behind in the hose.Let the water flow approximately 5 minutes before the first bath of the day.Clean and disinfect the bathtub according to the ifu before the first bath of the day and after the bath of each patient." sum up, the cause of (b)(6) developing in out baths, the customer's water installation has been contaminated by the customers supply in the first instance.To explain our findings and advise on what measures need to be taken to reduce (b)(6) from developing in their water supply, the customer was visited by our representative in (b)(4) 2017.In summary, the bath was alleged contaminated with (b)(6) and from that perspective the device was not performing up to manufacturer specification.The complaint was reported in abundance of caution, due to indicated microorganism on the bath system.However the investigation result showed that the source of bacteria was not the bath system, but the customer water supply installation.No adverse event was reported.It appears highly improbable that the involved bath system could have caused or contributed to death or serious injury.

• Brand Name: MALIBU
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6518152
• MDR Text Key: 74145642
• Report Number: 3007420694-2017-00099
• 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
• Report Date: 07/21/2017

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: AZL33116-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: 07/21/2017
• Distributor Facility Aware Date: 03/28/2017
• Device Age: 4 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/21/2017
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided; 03/28/2017
• Supplement Dates FDA Received: 05/23/2017; 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other