MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. SYSTEM 2000; BATH, HYDRO-MASSAGE

Model Number AR52311EU0110

Device Problem Device Contamination With Biological Material (2908)

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 a customer complaint regarding system 2000 bath.It was indicated that the bath was filled with water and the water samples taken after 24 hours have contained pseudomonas aeruginosa bacteria.The device was taken out of use after performing the test, there was 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.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

Arjohuntleigh has received a customer complaint regarding system 2000 bath.It was indicated that the water poured into the bathtub was contaminated with a bacteria: pseudomonas aeruginosa.The bacteria test was reported to be carried out from the water samples taken after 24 hours the bathtub was filled with water.The bath tub was taken out of use after performing the test.No injury was reported as a result of alleged contamination.This report concerns system 2000 bath with model number ar52311gb0110 and serial number (b)(4), located in (b)(6).The bath in question was 3 year old when the test for bacteria presence was conducted.When reviewing similar reportable events with the involvement of the system 2000 baths, we have found 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 currently considered to be low.From the information collected during the investigation we were able to establish that the following factors could have contributed to the reported contamination: contamination of installation supplied water to bath, following the information forwarded to us by customer, the facility had problem with poor quality of the water in the past.It seems possible that the pseudomonas contamination originates from the facility pipes or surroundings.It should be noted that the contaminated water in for example an hospital setting can transmit pseudomonas through direct contact with the water, either through ingesting or bathing or indirect contact from contaminated surfaces via caretakers hands.According to instruction for use (ifu 04.Ar.12 rev.6 as supplied with involved device), 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." neglected disinfection by device owner, according to recommendations describes in the ifu, the bath should be disinfected immediately after every use and before the first bath of the day.It seems very probable that the cleaning and disinfections instructions were not followed by the device owner because after cleaning of the bath using arjohuntleigh disinfectant, the problem was resolved (no pseudomonas aeruginosa was found in any of the 6 samples taken after decontamination of the bath).In addition, following to opinion of our technician concluded that the method used to take the initial samples of water maybe incorrect because it is recommended for swimming pools where the water continuously are running.Please note, that 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.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.Although that we are not able to establish the exact cause of the reported contamination, it seems most likely that the reported problem was related to contamination coming from external source and neglected maintenance.The arjohuntleigh bath system 2000 was confirmed to be not a source of the pseudomonas aeruginosa bacteria.Following the investigation conclusions, arjohuntleigh found reasonable to suggest the awareness to the customer about a need to follow the cleaning and disinfection instruction including microbiological formation prevention described in the ifu to guarantee a reduction of the contamination long term.In summary, the bath was alleged to be contaminated with pseudomonas aeruginosa bacteria and from that perspective the device was not performing up to manufacturer specification.The performed investigation confirmed that arjohuntleigh bathtub system was not a source of alleged contamination.The customer excluded the bath from use after receiving the test result.The complaint was reported in abundance of caution, due to indicated microorganism on the bath system.No injury was reported as a result of alleged contamination.

• Brand Name: SYSTEM 2000
• 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: 6672613
• MDR Text Key: 78987178
• Report Number: 3007420694-2017-00149
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017

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: AR52311EU0110
• 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: 10/10/2017
• Distributor Facility Aware Date: 03/03/2017
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/10/2017
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 03/03/2017; 09/11/2017
• Supplement Dates FDA Received: 07/25/2017; 10/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• 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