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U.S. Department of Health and Human Services

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

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VIVONIC GMBH AQUABPLUS, HF 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 03/25/2022
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 the concentrate pressure was too low on an aquabplus 1500. The reverse osmosis (ro) system was also displaying the following alarm codes: w-02-50-17 and w-02-51-03. The machine was in supply mode at the time of the reported failure. However, the biomed stated the failure had occurred at the very end of the day and no patients were in treatment at the time. The biomed stated there was a blown fuse (not a vivonic product) in the disconnect right before the aquabplus system. In addition, the thermal overload relay was reported to be tripping in stage 1. During the machine inspection, a burnt wire connector was identified on the load side of the motor protection switch (mps). The biomed described the appearance of the wire connector as blackened. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed said the affected wire was the one going from the mps to the thermal overload relay. To resolve the reported issue, the biomed replaced all three wires as well as the mps. The biomed confirmed there were no local power grid issues around the event date. Additionally, there were no blown fuses in the local power supply box. A photo was provided for review, along with the ftp machine files. The replaced parts were available to be returned for further evaluation.
 
Event Description
A user facility biomedical technician (biomed) reported that the concentrate pressure was too low on an aquabplus 1500. The reverse osmosis (ro) system was also displaying the following alarm codes: w-02-50-17 and w-02-51-03. The machine was in supply mode at the time of the reported failure. However, the biomed stated the failure had occurred at the very end of the day and no patients were in treatment at the time. The biomed stated there was a blown fuse (not a vivonic product) in the disconnect right before the aquabplus system. In addition, the thermal overload relay was reported to be tripping in stage 1. During the machine inspection, a burnt wire connector was identified on the load side of the motor protection switch (mps). The biomed described the appearance of the wire connector as blackened. There was no evidence of any burning smell, smoke, sparks, or flames. The biomed said the affected wire was the one going from the mps to the thermal overload relay. To resolve the reported issue, the biomed replaced all three wires as well as the mps. The biomed confirmed there were no local power grid issues around the event date. Additionally, there were no blown fuses in the local power supply box. A photo was provided for review, along with the ftp machine files. The replaced parts were available to be returned for further evaluation. Additional information was provided by the water system service (wss) specialist who assisted the biomed with the repair. The blown fuse was replaced and the stage 1 thermal overload was reset on the same day. However, the wires were not replaced at that time because the replacement wires had not yet arrived. No further details were provided.
 
Manufacturer Narrative
Additional information: plant investigation: no parts were returned to the manufacturer for physical evaluation. However, the reported failure pattern is a known issue, and thermal damage could clearly be seen in the provided picture. The reported event could be confirmed by reviewing the machine files in which error codes w-02-50-17 and w-02-51-03 were both identified. The blown fuse in the local power supply caused a tripped thermal overload switch in stage 1, and pump p1 stopped. As a result, both concentrate pressures p-c and p-cs dropped below the limit (6bar), and the error codes w-02-50-17 for stage 1 and w-02-51-03 for stage 2 were triggered. The issue was resolved on site by replacing the blown fuse and resetting the thermal overload. The correct fuse to use is described in service manual (sm). During troubleshooting, a discolored cable lug was found at motor protection switch stage 1. The cable lug at pin of l2 was burnt/discolored. The discolored cable lug is a known issue and has been addressed in a capa project. This device was manufactured before implementation of the capa, and since that time, corrective actions have been defined and implemented. A device history record (dhr) review was performed. The device was found to be conforming to the specifications and was confirmed to be released without any discrepancies. A review of the repair history was not required, and reproducing the reported failure was not necessary. As the reported failure is a known issue, no sample return was required. Reviews of the instructions for use (ifu) and sm were also not required; the provided information and review of the machine files were sufficient in determining a failure cause. Based on the information available, the reported event was confirmed. It was determined that the failure was caused by bad environmental conditions and not by the machine itself.
 
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Brand NameAQUABPLUS, HF 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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key14116191
MDR Text Key289313439
Report Number3010850471-2022-00008
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 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG02040105-US
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/22/2022
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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