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Catalog Number G02000970-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Event Description
A fresenius field service technician (fst) was called onsite by a user facility to repair an aquac uno h machine that was experiencing out-of-box issues. The reverse osmosis (ro) system was never fully installed, and the date installation began was unknown. It was reported that technicians from fresenius facilities are trained and certified to perform their own installations of aquac uno systems, and therefore fsts do not get involved. The installation process was not far along when the ro started smoking and then quit running. It was later clarified that there was no visible smoke. The biomedical technician (biomed) at the facility unplugged it and contacted isopure for troubleshooting assistance. The issue could not be resolved, and thus, an onsite evaluation was requested by the facility. A fresenius fst was dispatched to the facility to further evaluate the ro, and the extent of their troubleshooting activities was not reported. What was known is that the system was not fixed, and a different fst was then dispatched to the facility. The second fst discovered that the mother board (originally reported as getting ¿smoked¿) displayed signs of charring. It was confirmed there was no visible smoke, no burning smell, and no sparks or flames. The fst replaced it with a new mother board, and that one subsequently got ¿fried¿ (or ¿smoked¿) too. The fst departed the facility without fixing the machine and a third fst was contacted to provide further support. Through research, the third fst learned that the ¿smoked¿ boards could be related to a bad valve 36. Therefore, they ordered another mother board and a replacement valve 36 prior to going to the facility. When this fst first pulled the cover off the ro, they said it looked like the machine had been running for months. Clear evidence of leaking was found, and multiple components showed corrosion. The fst contacted the fresenius water systems service specialist and requested a replacement ro for the facility. Their justification for requesting this replacement was that the installation was never completed, and this was an out-of-box issue. The fst was encouraged to try fixing the system. When the fst removed valve 36, an abundance of green-colored corrosion was found underneath it. The biomed replaced valve 36 and the mother board. The fst was then able to power on the system without damaging the mother board; however, the ro would not pass the t1 test. Additionally, once the ro was put into supply mode, valve 22 and valve 10 began to leak. There was an unknown alarm that appeared at this time which indicated there was an issue with the break tank. The fst looked inside the break tank and observed orange, slimy water. Per the fst, the facility was unable to get the ro operating, and the water inside the break tank had been sitting there for a long time (possibly months). After a full day of troubleshooting, the fst was advised to go home and a replacement ro was ordered for the facility. There was no patient involvement associated with this reported issue. Photos and ftp machine files were provided for review. In addition, a sample was reportedly available for manufacturer evaluation.
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Manufacturer (Section D)
kurufuerst-eppstein-ring 4
sailauf 63877
GM 63877
Manufacturer (Section G)
kurufuerst-eppstein-ring 4
sailauf 63877
GM 63877
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
MDR Report Key12872854
MDR Text Key281263014
Report Number3010850471-2021-00031
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02000970-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse