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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION
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VIVONIC GMBH AQUABPLUS 2000; SUBSYSTEM, WATER PURIFICATION Back to Search Results
Catalog Number G02040107-US
Device Problem Thermal Decomposition of Device (1071)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2021
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 2000 machine experienced a pump issue.Upon further inspection, it was found that the terminal lug of l1 was burnt and two fuses were blown.To resolve the reported issue, the tip of the burnt lug was cut off and replaced with a new one, and the two blown fuses were replaced.The burnt lug was discarded, and so were the two blown fuses.Therefore, no samples were available to be returned to the manufacturer for evaluation.A photo of the burnt component was provided for review.There was no report of patient involvement associated with the event.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 2000 machine experienced a pump issue.Upon further inspection, it was found that the terminal lug of l1 was burnt and two fuses were blown.To resolve the reported issue, the tip of the burnt lug was cut off and replaced with a new one, and the two blown fuses were replaced.The burnt lug was discarded, and so were the two blown fuses.Therefore, no samples were available to be returned to the manufacturer for evaluation.A photo of the burnt component was provided for review.There was no report of patient involvement associated with the event.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.The review of the complaint history revealed that the reported event is a known problem.The reported event was confirmed based on a photo that was provided of the damaged machine component.Machine files for the event date could not be provided.In the available machine files, 142 power off/on cycles were identified as occurring during operation mode.In addition, the error code f-02-50-05 (a run-dry protection) occurred 50 times.Both failures could have damaged the motor protection switch and/or the connection cable/cable lug.There are several reasons a power off/on cycle may occur.It can occur when initiated manually by the operator, when a wdg failure occurs, or when there is a power failure.It is recommended to wait 120 seconds (at minimum) when restarting the system.It was found that a wdg failure occurred 64 times from (b)(6) 2020.The wdg failure is triggered when the internal cpu test routine fails.The review of the instructions for use (ifu) reveals that the correct fuse characteristics are adequately addressed.Additionally, review of the service manual (sm) revealed that regular visual inspections are adequately addressed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.Based on the provided photo, the reported problem was able to be confirmed.The issue was resolved onsite by replacing the cable lug and the blown fuses.
 
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Brand Name
AQUABPLUS 2000
Type of Device
SUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
VIVONIC GMBH
kurufuerst-eppstein-ring 4
sailauf 63877
GM  63877
MDR Report Key11255544
MDR Text Key229528131
Report Number3010850471-2021-00002
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
PMA/PMN Number
K133829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
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? No
Device AgeMO
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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