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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2500; SUBSYSTEM, WATER PURIFICATION
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VIVONIC GMBH AQUABPLUS 2500; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040108-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2021
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 user facility biomedical technician (biomed) reported finding thermal damage on the motor protection switch (mps) from an aquabplus 2500.There were blackened/burnt wires on the back of the mps.Additional information was received from the area technical operations manager (atom), who was aware of the events.The atom stated the clinic lost power during operation.It was suspected that they lost 1 leg of the 3-phase system.The atom stated the issue was caused by a city transformer.Once power was restored to the facility, the hood of the aquabplus was lifted to inspect for damage.This is when the burnt wires were identified.Although the wires were damaged, the reverse osmosis (ro) system was still working.The atom stated that it was operating without any issues when they powered it back on, and there were no alarm codes displayed.Treatments were delayed due to the power outage, but there was no patient harm or injury.A few patients reportedly elected to go home without completing treatment, but the majority of patients waited for power to be restored.There were no adverse events due to any delayed or incomplete treatments.Furthermore, there was no direct patient involvement; the patients do not connect to the ro system.There was no evidence of any burning smell, smoke, sparks, or flames.The atom confirmed that the thermal overload switch was not tripping.The atom also reported that there were no blown fuses in the local power supply.As a precaution, the mps and burnt wires were replaced.Photos of the burnt wires were provided for review, and so were the ftp machine files.The atom stated they would contact their local water specialist contact to set up a returned goods authorization (rga) for the parts to be sent back for evaluation.
 
Event Description
A user facility biomedical technician (biomed) reported finding thermal damage on the motor protection switch (mps) from an aquabplus 2500.There were blackened/burnt wires on the back of the mps.Additional information was received from the area technical operations manager (atom), who was aware of the events.The atom stated the clinic lost power during operation.It was suspected that they lost 1 leg of the 3-phase system.The atom stated the issue was caused by a city transformer.Once power was restored to the facility, the hood of the aquabplus was lifted to inspect for damage.This is when the burnt wires were identified.Although the wires were damaged, the reverse osmosis (ro) system was still working.The atom stated that it was operating without any issues when they powered it back on, and there were no alarm codes displayed.Treatments were delayed due to the power outage, but there was no patient harm or injury.A few patients reportedly elected to go home without completing treatment, but the majority of patients waited for power to be restored.There were no adverse events due to any delayed or incomplete treatments.Furthermore, there was no direct patient involvement; the patients do not connect to the ro system.There was no evidence of any burning smell, smoke, sparks, or flames.The atom confirmed that the thermal overload switch was not tripping.The atom also reported that there were no blown fuses in the local power supply.As a precaution, the mps and burnt wires were replaced.Photos of the burnt wires were provided for review, and so were the ftp machine files.The atom stated they would contact their local water specialist contact to set up a returned goods authorization (rga) for the parts to be sent back for evaluation.
 
Manufacturer Narrative
Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.The reported event was confirmed based on photos that were provided of the damaged wires, in addition to the ftp data files.A review of similar complaints was not required in this case.Despite the thermal damage found on the wires and blade receptacles, the motor protection switch (mps) was still functional after the power supply issue was fixed.The reported failure patterns are known and are being addressed under capa projects.After reviewing the provided photos, poor electrical contact at the motor protection switch can be considered a contributing factor as cause for the reported damage.This also results in thermal stress at the wires and blade receptacles and may lead to heat damage.The device history record (dhr) review found the device to be conforming to specifications and released without any discrepancies.No separate review of the service history was required.As the failure patterns are known, no investigation of any single component was required.A review of the service manual was also not required, as the failure patterns are known and being addressed through the capa projects.The review of the instructions for use (ifu) reveals that the waiting period after resetting a triggered motor protection switch is adequately addressed.It is recommended to use the spare parts which are mentioned in a change notification where the wire and crimp connection were given an improved design for the electrical connection at the motor protection switch.Based on the available information, the reported problem was able to be confirmed.
 
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Brand Name
AQUABPLUS 2500
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM  63877
Manufacturer (Section G)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
director of quality
sailauf 63877
GM   63877
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12586899
MDR Text Key275123113
Report Number3010850471-2021-00027
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 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
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
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received10/20/2021
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 Number1
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