• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

VIVONIC GMBH AQUABPLUS 1500 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040105-US
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2021
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported that the motor protection switch (mps) from an aquabplus 1500 was tripping at the pump start and thermal damage was found on the wires from stage 1 of the power switch. There was no report of any patient involvement. The biomed received a call from the hemodialysis (hd) clinic because the system would not turn on. When the biomed arrived at the facility, they noticed the mps would reset, but as soon as the pump for stage 1 started, the mps would trip. The biomed was able to get the display to work, which allowed them to run the system in emergency mode 2. Though some treatments were delayed by approximately ninety minutes, there were no missed treatments or adverse events that occurred. Upon further inspection of the machine, the biomed found charring on the connectors of the wires connected to the mps. The connectors reportedly appeared melted. To resolve the reported issue, the mps and wires were replaced. There were no blown fuses found at that particular time. Two days after the repair, a fuse blew in the swt local power supply box. The fuse that blew was a 25 amp fuse. The fuse was replaced and there were no further issues. There were no local power grid issues around the date of the event. It was also confirmed that the thermal overload switch was not tripping. There was no sample available for manufacturer evaluation; the damaged parts were reportedly discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12133275
MDR Text Key260412133
Report Number3010850471-2021-00022
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 08/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/27/2021
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

-
-