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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION

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VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
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 (biomed) reported that an aquabplus 1500 had no display. There were no corresponding alarm codes on the system. This occurred on a day when the clinic was not open for dialysis treatments, and therefore, there was no patient involvement. During the biomeds inspection of the system, they identified burn marks on the 24 dc cable that connects from the 24v board to the motherboard. Burn marks were also visible on the motherboard itself. To resolve the reported issue, the biomed replaced the burnt parts with the motherboard and 24 dc cable from the second stage. During troubleshooting with a technician, the biomed was told this was an acceptable solution so long as the biomed didnt need to put the system into emergency mode 2. After performing the swap, the machine was able to operate in stage 1 (standard mode) without any further issues. The biomed confirmed there were no blown fuses in the local power supply, and there were no local power grid issues around the time of the event. No further damage was identified on any other machine components. The biomed affirmed that there was no evidence of any burning smell, smoke, sparks, or flames. They also confirmed that the thermal overload switch was not tripping. Photos of the burnt parts were provided for review, and the ftp files were also provided. The samples are available to be sent back for evaluation.
 
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Brand NameAQUABPLUS 1500
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 Key12021986
MDR Text Key256881453
Report Number3010850471-2021-00018
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,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040105-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/06/2021
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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