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

Model Number AR32311GB0111

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2017

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 positive for contamination with pseudomonas.Currently arjohuntleigh is in the process of gathering information about possible root cause of the contamination.

Manufacturer Narrative

On (b)(6) 2017 arjohuntleigh has been informed by customer (b)(6) that based on the results of microbiological tests, (b)(6) department ceased further usage of the system 2000 bath (serial number (b)(4)) due to excessive levels of pseudomonas aeruginosa bacteria and aerobic colony count.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 spread by equipment that gets contaminated and is not properly cleaned and maintained.On 2017-jul-07 the arjohuntleigh representative visited the (b)(6) to inspect the claimed bathtub.The arjohuntleigh representative found that the water pressure during the disinfectant stage was too low.It was suggested to the customer to increase the water pressure during disinfection of the bathtub.After implementation of changes leading to the water pressure increase, on 2017-sep-20 next swabs were taken to verify if bacteria presence was reduced to an acceptable level.Based on the ehs officer report an unsatisfactory pseudomonas aeruginosa count is >10 per 100ml and an unsatisfactory aerobic colony count is >10 per 100ml.The test results confirmed that bacterium level was reduced below the level established by ehs and are therefore satisfactory.Next samples were taken on 2017-oct-04 and results were acceptable as well.In summary, the complaint was decided to be reportable based on the allegation that arjohuntleigh bath system 2000 is contaminated with bacteria.During the investigation it became evident that bath system was not source of the pseudomonas aeruginosa bacterium - increase of water pressure in disinfection stage eliminated the bacteria and resolved the issue.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 state of health.Therefore this type of event will no longer be seen as reportable complaint.

• Brand Name: SYSTEM 2000
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP Z O.O; ks. wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6735209
• MDR Text Key: 80801365
• Report Number: 3007420694-2017-00160
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Report Date: 10/31/2017

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: AR32311GB0111
• 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: 10/31/2017
• Distributor Facility Aware Date: 06/28/2017
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 10/31/2017
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 10/04/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2017
• 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