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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS, HF 2000; SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS, HF 2000; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number AQUABPLUS
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
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 reported to fresenius technical support that an aquabplus, hf 2000 experienced no power to the display.Upon troubleshooting, a burnt wire was discovered on the power supply board.The biomedical technician removed the power supply from stage 2 and placed it into the stage 1.The biomedical technician also removed the cable from the power supply board to the mother board, and replaced the cable with the red/blue cable from stage 2 to resolve the reported issue and the machine was returned to service.There was no patient involvement, harm, or adverse events reported as a result of this issue.After the documented follow up attempts, no further information has become available and no response from the customer has been received.If additional information becomes available, the file will be updated and processed accordingly.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.A review of the machine files was not needed as the described failure pattern is a known problem.The complaint investigation determined there was a bad/overheated electrical contact at the power supply unit on stage 1.The bad electrical contact is caused by an improper manufacturing process of this crimp and plug connection.The contact pressure inside the housing of this plug connector was too low at the power supply unit and this resulted in thermal stress until the contact get completely damaged over the time of device operation.This failure pattern is known and the implementation of corrective actions are currently in progress.The new manufacturing process is not approved yet and not available for possible spare part order.The device was built and delivered before the manufacturing process was reviewed within the performed root cause analysis.The failure pattern is known and a capa was assigned to this complaint record, any threshold exceedance is not relevant.Device history record (dhr) review was not performed.No separate review of the service history was required.Reproducing the reported failure pattern was not necessary, as the failure type is a known issue.Based on the available information, the reported problem was able to be confirmed.
 
Event Description
A user facility biomedical technician reported to fresenius technical support that an aquabplus, hf 2000 experienced no power to the display.Upon troubleshooting, a burnt wire was discovered on the power supply board.The biomedical technician removed the power supply from stage 2 and placed it into the stage 1.The biomedical technician also removed the cable from the power supply board to the mother board, and replaced the cable with the red/blue cable from stage 2 to resolve the reported issue and the machine was returned to service.There was no patient involvement, harm, or adverse events reported as a result of this issue.After the documented follow up attempts, no further information has become available and no response from the customer has been received.If additional information becomes available, the file will be updated and processed accordingly.
 
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Brand Name
AQUABPLUS, HF 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15140907
MDR Text Key297001518
Report Number3010850471-2022-00017
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 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAQUABPLUS
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 07/14/2022
Initial Date FDA Received08/01/2022
Supplement Dates Manufacturer Received08/10/2022
Supplement Dates FDA Received08/19/2022
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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