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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION
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VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040107-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 failed to turn off in stage 1, even with the power switch in the off position.The biomed stated the display was still on, but the switch was off.There were no issues with stage 2.The reverse osmosis (ro) system was in standby mode at the time of the reported failure.There was no patient involvement associated with the event.The biomed stated there were no alarm codes displayed on the ro.The biomed unplugged the ro and this temporarily resolved the issue.During inspection of the system, the biomed discovered that the cable connectors plugged into the motor protection switch (mps) were burnt.The biomed also noticed a mild burning smell.The biomed replaced the connectors and the mps, and the mps was returned for evaluation.The biomed confirmed the thermal overload switch was not tripping and there were no blown fuses in the local power supply.Additionally, the biomed confirmed there were no known local power grid issues at the time of the event.There was no evidence of any smoke, sparks, or flames.The machine files were provided for review, along with a photo of the burnt cable connectors.At the time of follow-up, the biomed stated the ro was fully operational and has not experienced any further issues.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
Additional information: h3 plant investigation: the reported failure pattern is a known issue and the burnt cable lugs were visible in the provided photo.The burnt cable lugs can be attributed to a contacting problem between the crimped cable lug of main phase l1 and its contact pin at the motor protection switch (mps).The reported complaint falls under a capa that was created to address this failure pattern.The design of the crimped cable lug was changed.The affected device was manufactured before implementation of the capa, and since then, corrective actions were defined and have been implemented.The described behavior of the aquabplus failing to turn off in stage 1 could not be retraced within the machine files investigation.Within the operational mode file, three power off / power on switching cycles were logged correctly on the event date, which does not indicate there were issues with the switch of stage 1.Instead, error code f-04-51-04 was logged on the event date indicating a problem of reaching the required 5 bar at p-c(2) within the t1-test of pump p1s.This could be retraced in the operational record file.The p-c(s) was not exceeding 3.3 bar.The reason for this could be a tripped mps due to bad contacting of the wires at the motor protection switch, which could lead to a missing line conductor.The rinse cycle before error f-04-51-04 occurred was performed successfully without any suspicious loggings.A device history record (dhr) review was performed.The device was found to be conforming to the specifications and was confirmed to be released without any discrepancies.No investigation of the concerned components was necessary, and a separate review of the repair history was not required.Reproducing the reported failure pattern was also not necessary.Based on the information available and the provided picture, the reported event was confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 failed to turn off in stage 1, even with the power switch in the off position.The biomed stated the display was still on, but the switch was off.There were no issues with stage 2.The reverse osmosis (ro) system was in standby mode at the time of the reported failure.There was no patient involvement associated with the event.The biomed stated there were no alarm codes displayed on the ro.The biomed unplugged the ro and this temporarily resolved the issue.During inspection of the system, the biomed discovered that the cable connectors plugged into the motor protection switch (mps) were burnt.The biomed also noticed a mild burning smell.The biomed replaced the connectors and the mps, and the mps was returned for evaluation.The biomed confirmed the thermal overload switch was not tripping and there were no blown fuses in the local power supply.Additionally, the biomed confirmed there were no known local power grid issues at the time of the event.There was no evidence of any smoke, sparks, or flames.The machine files were provided for review, along with a photo of the burnt cable connectors.At the time of follow-up, the biomed stated the ro was fully operational and has not experienced any further issues.
 
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Brand Name
AQUABPLUS 2000
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 Key13386255
MDR Text Key284637645
Report Number3010850471-2022-00004
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133829
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 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/15/2022
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 Number1
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