• 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 2000 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 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 06/02/2021
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 finding a burnt wire going from the motor protection switch (mps) to the power contactor on an aquabplus 2000. The biomed stated the mps kept cutting off while in supply mode. The biomed opened the hood of the system to further evaluate and they noticed a mild burning smell. This is when they saw that one of the wires going from the mps to the power contactor was completely burnt and severed. The wire was no longer connected to the mps. One end of the severed wire was fused to the mps, and the mps also displayed some evidence of visible thermal damage. Aside from the burnt wire, there were no other loose or disconnected wires found in the monitor or elsewhere. The biomed confirmed that the thermal overload switch was not tripping. The biomed used a wire cutter to slice off the burnt part and reconnected it to a new cap. They then replaced the mps with a spare one. After replacing the mps and reconnecting the repaired wire to it, there were no further issues. As a precautionary measure, the biomed reported turning down the amps on the aquabplus from 18 to 15, to reduce the level of energy coming through the system. There were no error codes displayed during the failure. The biomed stated there were no blown fuses in the local power supply and there were no local power grid issues around the date of the event. The biomed confirmed the machine issue had been fully resolved. Treatments were delayed by one hour, but there were no missed treatments or patient adverse events. There was no direct patient involvement. A photo of the burnt wire was provided for review, as were the machine data files. The mps (with part of the burnt wire still attached) was reportedly returned for evaluation.
 
Event Description
A user facility biomedical technician (biomed) reported finding a burnt wire going from the motor protection switch (mps) to the power contactor on an aquabplus 2000. The biomed stated the mps kept cutting off while in supply mode. The biomed opened the hood of the system to further evaluate and they noticed a mild burning smell. This is when they saw that one of the wires going from the mps to the power contactor was completely burnt and severed. The wire was no longer connected to the mps. One end of the severed wire was fused to the mps, and the mps also displayed some evidence of visible thermal damage. Aside from the burnt wire, there were no other loose or disconnected wires found in the monitor or elsewhere. The biomed confirmed that the thermal overload switch was not tripping. The biomed used a wire cutter to slice off the burnt part and reconnected it to a new cap. They then replaced the mps with a spare one. After replacing the mps and reconnecting the repaired wire to it, there were no further issues. As a precautionary measure, the biomed reported turning down the amps on the aquabpluss from 18 to 15, ¿to reduce the level of energy coming through¿ the system. There were no error codes displayed during the failure. The biomed stated there were no blown fuses in the local power supply and there were no local power grid issues around the date of the event. The biomed confirmed the machine issue had been fully resolved. Treatments were delayed by one hour, but there were no missed treatments or patient adverse events. There was no direct patient involvement. A photo of the burnt wire was provided for review, as were the machine data files. The mps (with part of the burnt wire still attached) was reportedly returned for evaluation.
 
Manufacturer Narrative
Plant investigation: the reported failure pattern is known and can be confirmed based on the performed ftp data review and provided pictures. The provided picture reveals charring of the wires and blade receptacles. One wire came completely loose due to the overheating. It was reported that the overload relay was adjusted by the biomed from 18a to 15a, both values that are not according to specification. The recommended specified value is 14. 4a. The ftp data confirmed the failure occurrence. The reason for the tripped motor protection switch is most likely a bad electrical contact at the motor protection switch, which led in to a tripping bimetal contact inside the main switch/motor protection switch. The contact and blade receptacle got overheated, as well the wire by the transition heat. Most likely by opening the electrical monitor the damaged and overheated wire got completely loose. In comparison to other devices with the same permeate capacity, this device has quite a low concentrate pressure of approximately 6. 5 bar in both stages. The rotary field respectively pump rotation direction should be checked. Usually the pump pressures higher, at 7. 5-9 bar. In addition to the reported failure, a likely defective sd card was determined during ftp data review. The failure pattern of a corrupted sd card is also a known issue. On the event date, there was a documentation gap found. The review of the device history records (dhr) was found to be unnecessary. No separate review of the service history was required. Reproducing the reported failure was also not required. No review of the instructions for use or service manual was required. The design of the crimp and blade receptacle will be changed in the new design. Based on the available information, the reported failure was able to be confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAQUABPLUS 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12028515
MDR Text Key257107519
Report Number3010850471-2021-00021
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 07/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberG02040107-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 Received06/26/2021
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

-
-