MAUDE Adverse Event Report: VIVONIC GMBH AQUAC UNO H; SUBSYSTEM, WATER PURIFICATION

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.

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.During review of the provided ftp machine files, error codes f-02-60-06 and w-01-60-11 were found.The failure cause for error code f-02-60-06 was most likely a defective valve coil of valve v36.The valve coil likely caused a short circuit which destroyed the integrated circuit (ic) and the motherboard.In the provided photo of the motherboard, the burnt ic can be seen.The other error code, w-01-60-11 (pump p2 defective), was most likely caused by the motherboard being defective.Leakages can be confirmed by the attached pictures.This failure pattern is unknown.The device was never in-use for treatments as the installation/operational qualification was never successfully completed.It cannot be excluded that the reported leakage caused the damage at valve v36.Regarding the reported slime (or biofilm), it was determined that the device was unplugged several days without preservation which can cause microbiological growth.Concerning the reported leakages, no cause could be determined as no parts were received for investigation.The device did pass all required tests within the manufacturing/testing procedure.However, the device history record (dhr) review found that the motherboard was replaced during a testing procedure due to pump1 not working.The required test steps were then repeated and passed.There were no leakages detected during testing.No separate review of the service history was required, and reproducing the reported failure is not applicable.

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.

• Brand Name: AQUAC UNO H
• Type of Device: SUBSYSTEM, WATER PURIFICATION
• Manufacturer (Section D): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer (Section G): VIVONIC GMBH; kurufuerst-eppstein-ring 4; sailauf 63877 ; GM 63877
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12872854
• MDR Text Key: 281263014
• Report Number: 3010850471-2021-00031
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143617
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: G02000970-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/30/2021
• 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
• Patient Sequence Number: 1