Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500; SUBSYSTEM, WATER PURIFICATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VIVONIC GMBH AQUABPLUS 2500; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problems Smoking (1585); Arcing (2583); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) reported that an aquabplus 2500 from one of their facilities had a motor protection switch failure.It was reported that the power on the system tripped and the machine would not run.Simultaneously, smoke was seen coming from the thermal contactor below the motor protection switch.The atom stated that it was not a lot of smoke and confirmed that the smoke detector did not go off.A burning smell was also noticed.The atom tried turning the machine back on to run it in emergency mode.As they did this, sparks and arcing were noted coming from the wires down by the contactor.The atom stated that the hood of the reverse osmosis (ro) system was closed, so they were unable to see inside of it.There were no reports of flames.In addition, there were no reported alarms.Patients were in treatment when the failure occurred, but there were no adverse events as a result.The atom stated the facility has two separate ro systems, and the patients who were in treatment were relocated to the other half of the treatment floor where they utilized the other ro system to complete their treatments.The event did not result in any incomplete treatments.To repair the aquabplus 2500, the atom replaced the motor protection switch, the thermal contactor, the relay, and ancillary wiring.The atom stated the damaged parts were returned for manufacturer evaluation.The aquabplus 2500 was returned to service and reported to be fully operational.As patients do not hook up to ro systems, there is no direct patient involvement associated with this event.
 
Event Description
An area technical operations manager (atom) reported that an aquabplus 2500 from one of their facilities had a motor protection switch failure.It was reported that the power on the system tripped and the machine would not run.Simultaneously, smoke was seen coming from the thermal contactor below the motor protection switch.The atom stated that it was not a lot of smoke and confirmed that the smoke detector did not go off.A burning smell was also noticed.The atom tried turning the machine back on to run it in emergency mode.As they did this, sparks and arcing were noted coming from the wires down by the contactor.The atom stated that the hood of the reverse osmosis (ro) system was closed, so they were unable to see inside of it.There were no reports of flames.In addition, there were no reported alarms.Patients were in treatment when the failure occurred, but there were no adverse events as a result.The atom stated the facility has two separate ro systems, and the patients who were in treatment were relocated to the other half of the treatment floor where they utilized the other ro system to complete their treatments.The event did not result in any incomplete treatments.To repair the aquabplus 2500, the atom replaced the motor protection switch, the thermal contactor, the relay, and ancillary wiring.The atom stated the damaged parts were returned for manufacturer evaluation.The aquabplus 2500 was returned to service and reported to be fully operational.As patients do not hook up to ro systems, there is no direct patient involvement associated with this event.In additional follow-up, the atom confirmed there were no fuses blown in the power supply.In addition, they reported that the machine had been running for hours leading up to the event.The machine was not turned on/off within a short time frame.The atom also provided clarification on when the sparks and arcing were seen.They said the hood was closed and the system was running when the burning smell was noted, prior to seeing any sparks or arcing.The atom turned the system off, opened the hood, and then contacted vivonic technical support for assistance.The technical support specialist advised the atom to turn the machine back on, while the hood was open.When the atom turned the machine on, they saw sparks and arcing coming from the wires down by the contactor.The atom was unable to see this when the burning smell was first noted because the hood was closed.No further details were provided.
 
Manufacturer Narrative
Plant investigation: no parts have been returned to the manufacturer for physical evaluation.A review of the complaint history revealed that the reported event is a known problem.The reported event was confirmed based on provided photos, and a review of the machine files was not necessary.The review of the instructions for use (ifu) was not required as the regular visual inspection is not user related.Review of the service manual (sm) revealed that the regular visual inspections are adequately addressed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.Based on the provided photos, the reported problem was able to be confirmed.The issue was resolved by replacing the motor protection switch, the wiring, the thermal overload switch, and the contactor.The technician confirmed that there was no blown fuse and no power break; the machine was running constant.The event was most likely triggered by increased contact resistance caused by improper insertion or slipping of the cable lug.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AQUABPLUS 2500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
MDR Report Key11605865
MDR Text Key243494082
Report Number3010850471-2021-00008
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040108-US
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-