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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 04/14/2021
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. A review of the complaint history is not required in this case as the failure pattern is known. The reported issue was able to be confirmed based on the ftp data review, in which the failure is clearly shown. The issue was most likely caused by a faulty valve v30s. Normally, the valve v30s opens only for one second during the t1 test to reduce pressure in the vessels of the 2nd stage. But if valve v30s is stuck open, the concentrate pressure p-cs is very low and close to the 5bar limit during the t1 test. A replacement of the valve v30s is recommended. Furthermore, a check and cleaning (if required) of the pretreatment and the soft feed water quality is recommended. Review of the instructions for use (ifu) and service manual (sm) revealed that the reported error code is adequately addressed. The device history records (dhr) were reviewed and the device was found to be conforming to the specifications. In addition, it was confirmed the device was released without any discrepancies. Based on the ftp data, the reported problem was able to be confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 experienced a failure of p1-s during the t1 test. The machine alarmed "f-04-51-04" in supply mode. It was found that the power switch on the 2nd stage had scorched connectors. To resolve the reported issue, the biomed replaced the connector with new wiring and all 5 membranes in stage 1. There was no report of patient involvement associated with the event. However, the start of treatments got delayed by an hour. Despite the delays, there was no reported harm due to the issue. It was confirmed the ro was placed into emergency mode 2. The biomed explained the 1st stage was not producing enough water and the 2nd stage could not run in emergency mode 1, only in emergency mode 2. At the time of follow-up, the machine had been returned to service and no parts were available for return.
 
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Brand NameAQUABPLUS 2000
Type of DeviceSUBSYSTEM, 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11916831
MDR Text Key253677374
Report Number3010850471-2021-00015
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/12/2021
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

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