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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 Patient Involvement (2645)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. The review of the complaint history revealed that the reported event is a known problem. The reported event can be confirmed by means of the provided photo. Although machine files were requested for review, the sd card from the system was found to be corrupted. 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 photo, the reported problem was able to be confirmed.
 
Event Description
A user facility's biomedical technician (biomed) reported that an aquabplus 2500 system had a motor protection switch failure. Patient treatments were interrupted for twenty minutes due to the failure. The machine was put in emergency mode and treatments were resumed. The machine ran in emergency mode for two days to allow patient treatments to continue. There were no indications of any adverse events, or patient injuries requiring medical intervention. After the motor protection switch was replaced, the system was returned to regular mode. Upon follow-up with the biomed, a photo of the defective motor protection switch was provided. In the photo, evidence of thermal damage was present on the component. The sample was not available to be returned for manufacturer evaluation. Machine files were requested but could not be provided; the system's sd card was found to be corrupted.
 
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Brand NameAQUABPLUS 2500
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 Key10807647
MDR Text Key215246984
Report Number3010850471-2020-00009
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 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040108-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 Received10/19/2020
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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