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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
Model Number AQUABPLUS 2500
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
A manufacturer investigation is in progress. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
(b)(6), an installation logistics manager for vivonics, reported that an aquabplus 2500 reverse osmosis machine, located at a user facility, was removed from service due to a t1 test failure that occurred during set-up for hemodialysis (hd) use. It was reported to henry, by the user facility biomedical technician (biomed), that the sd card was burnt and there was an issue with the motherboard. This information was reported to fmcna rtg on (b)(6) 2018 during a conference call. The hd patients at this facility were able to receive treatment at another facility until the unit was repaired. There was no harm to any patients or individuals due to this event. There was no report of heat damage to the machine¿s other components. The biomed replaced the sd card and motherboard to resolve the issue. The unit was returned to service at the user facility without a recurrence of the event as reported. The sd card was stated to be available to be returned to vivonic for physical evaluation.
 
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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
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7234041
MDR Text Key98984541
Report Number3010850471-2018-00001
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAQUABPLUS 2500
Device Catalogue NumberG02040108-US
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
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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