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

Model Number AZR33116-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: colten care, uk 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

(b)(4).(b)(4) 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 then (b)(6) 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

Arjohuntleigh received information about 5 complaints raised by one particular customer facility (b)(6).Following the information provided by (b)(6) (which was providing a water test results for (b)(6)), a pseudomonas aeruginosa 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 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).The customer facility representative did not disclose whether the system has already been used, or not.As a precautionary measure, the customer decided to take the baths out of use until the bath was decontaminated by 3rd party water treatment consultancy services (b)(6).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 very low.The investigation including analysis of potential sources of contamination allowed to exclude the manufacturing process as the source of bacteria.The water supply used during the manufacturing and testing processes was found to be free of bacteria (negative result for pseudomonas presence).It was confirmed that the swabs taken from cold/hot inlets, tap and filter were negative.Based on the review of previous complaints, we (arjohuntleigh) noticed different causes of pseudomonas aeruginosa developing such as for example: contamination of the customer's water installation, neglected maintenance of the device.In this case, we are not able to identify the cause of alleged contamination.General conclusion of root cause analysis is that many sources of the bacteria might be defined because the pseudomonas 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.To guarantee a reduction of the contamination long term, 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." in summary, the bath was alleged contaminated with pseudomonas aeruginosa and from that perspective the device was not performing to manufacturer specification.The complaint was reported due to indicated microorganism on the bath system.The arjohuntleigh bath malibu was confirmed to be not a source of the pseudomonas aeruginosa bacteria.No adverse event was reported.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: 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: 6518007
• MDR Text Key: 73613239
• Report Number: 3007420694-2017-00097
• 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,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: AZR33116-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: 11/30/2017
• Distributor Facility Aware Date: 03/28/2017
• Device Age: 6 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided; 03/28/2017; 10/05/2017; 10/05/2017
• Supplement Dates FDA Received: 05/23/2017; 07/18/2017; 10/31/2017; 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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