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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
Catalog Number G02040107-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 experienced a p1 pump failure and displayed the following alarm code: w-02-50-17. The biomed stated this occurred before the clinic had opened; there was no patient involvement. It was reported that the concentrate pressure was too low; it would not produce greater than approximately 4 bar from the first stage. During the machine inspection, thermal damage was identified on the power supply unit (psu) and the red cable on the psu. To resolve the reported issue, the biomed replaced the power supply unit, the power supply cable, and the p1 pump. No additional damage was found. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed confirmed the thermal overload switch was not tripping, and there were no blown fuses in the local power supply. Additionally, there were no local power grid issues at the time of the event. Photos were provided for review, in addition to the ftp machine files. The biomed stated the parts were available to be returned for further evaluation.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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Brand NameAQUABPLUS, HF 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14377174
MDR Text Key291521293
Report Number3010850471-2022-00012
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 06/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040107-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/16/2022
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

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