MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SYSTEM 2000

Model Number AP31101-EU

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303); Environmental Compatibility Problem (2929)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

The event in complaint (b)(4) has described to us as follows by the arjohuntleigh representative who visited the customer site and inspected the device, as documented in the complaint file: "customer has, through measurement of housing association, noted that there is legionella from the bath {nozzle and bath filler).After this, there has been further investigation if there is anything else found elsewhere legionella.That is observed.After this one has cleaned the dwelling and measured again.After that we have replaced the porous parts and rinsed with a chlorine solution to kill everything and get clean." from the information received there is no indication that any injury occurred to the patient or caregiver.Additional information provided by the originator of this complaint 2014-(b)(6): hot water at the customer was stable during device examination.The customer have heat and hot water supply.It is unknown how often the customer is disinfecting the bath.When they disinfect, the hydro is also included.Bath has been tested many times.It has after the first measurement, first internally everything (in the building) cleaned to know that the piping etc are definitely clean.After that we were there to clean our bathtub.(b)(6), 2014: "yes, high concentration was in the building.Legionella is there in the water but low concentrate.When the environment is okay (temperature) it is easy to increase which causes the problem.But as said before, in standard tap is legionella.".

Manufacturer Narrative

(b)(4).As of 2014 that number was de activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's.An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 and other baths, we have low number of other cases with similar fault description (legionella issue or bacteria indication).We have been able to establish that there is a slightly increasing but very low complaint trend concerning legionella issue in baths recorded under brand name: system 2000.(b)(4).Please note that arjohuntleigh manufactured about 32000 system 2000 bath to date.With the amount of sold devices and with comparison to the daily use of them the trend observed for complaints with this failure mode is considered to be acceptable.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification.The device was being used for patient handling and in that way contributed to the event.The instruction for use (ifu 04.Ar.09/8gb from october 2006) provides information for users about cleaning the bath.Always make sure: "equipment is properly disinfected after each bath".If the recommendations in the assembly and installation instructions were followed and the hot and cold water temperature was under control it is unlikely for legionella to be found in the bath.Please note that this complained bath bas been in use for over 7 years.On 2014-11-27, the originator of this complaint confirmed that problem was caused by water quality at the customer: "yes, high concentration was in the building.Legionella is there in the water but low concentrate.When the environment is okay (temperature) it is easy to increase which causes the problem.But as said before, in standard tap is legionella." the most possible root causes of this problem are: quality of supplied water in facility- above confirmation showed that it is not likely that contamination was caused by the device itself, the most possible cause is water temperature supplied at the.Lack or incorrect maintenance - baths should be disinfected after each use.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 ; PL 0000
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 4307712
• MDR Text Key: 5273947
• Report Number: 3007420694-2014-00119
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/03/2014,11/05/2014

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: Other
• Device Model Number: AP31101-EU
• 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: 12/03/2014
• Distributor Facility Aware Date: 11/05/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/03/2014
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• 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