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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 05/20/2021
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 machine had a t1 test failure. It was reported that pump p1s was defective. The system displayed alarm code "f-04-51-04" during the failure. There was good voltage on the line side of the red/green power switch, but the voltage going to the power contactor in the second stage was weak. The technician providing troubleshooting support recommended replacing the defective motor protection switch (mps). During the initial inspection, no burnt or scorched parts were observed. The biomed stated that they replaced the power switch in this system a few months ago. The technician providing support also recommended inspecting the wire connections in the power circuit for tightness, and to check the pump direction after the repair. Upon follow-up with the biomed it was confirmed that the blade receptacle had not loosened from the mps. The biomed stated the switch was in the on position prior to the failure, and it automatically switched to the off position [when the failure occurred]. The biomed could not recall the exact voltage reading, but reported that the l2-l3 voltage was significantly lower than the others. The biomed also stated there was discoloration on the back of the mps, as well as on the wiring which was replaced. The discoloration was described as black, and it was associated with a burning smell. The mps and blackened wire(s) were replaced to resolve the issue. There was no patient involvement, no patient harm, or adverse event reported at intake. It is unknown if the sample is available to be returned for evaluation.
 
Event Description
A user facility biomedical technician (biomed) reported that an aquabplus 1500 machine had a t1 test failure. It was reported that pump p1s was defective. The system displayed alarm code "f-04-51-04" during the failure. There was good voltage on the line side of the red/green power switch, but the voltage going to the power contactor in the second stage was weak. The technician providing troubleshooting support recommended replacing the defective motor protection switch (mps). During the initial inspection, no burnt or scorched parts were observed. The biomed stated that they replaced the power switch in this system a few months ago. The technician providing support also recommended inspecting the wire connections in the power circuit for tightness, and to check the pump direction after the repair. Upon follow-up with the biomed it was confirmed that the blade receptacle had not loosened from the mps. The biomed stated the switch was in the on position prior to the failure, and it automatically switched to the off position [when the failure occurred]. The biomed could not recall the exact voltage reading, but reported that the l2-l3 voltage was significantly lower than the others. The biomed also stated there was discoloration on the back of the mps, as well as on the wiring which was replaced. The discoloration was described as black, and it was associated with a burning smell. The mps and blackened wire(s) were replaced to resolve the issue. There was no patient involvement, no patient harm, or adverse event reported at intake. It is unknown if the sample is available to be returned for evaluation.
 
Manufacturer Narrative
Plant investigation: the reported event can be confirmed by means of the provided picture and the provided machine files. The failure can be attributed to a contacting problem between the blade receptacle and the contact pin of a mains phase from the motor protection switch (mps). The reported error code (f-04-51-04) was identified four times in the machine files on the reported event date. This code indicates a defect in the second stage booster pump p1s, during the t1 functional startup test. This was caused by a faulty motor circuit breaker due to contact problems with the blade receptacle. There was most likely an improper connection of the blade receptacle on contact pin l2 of the motor protection switch, which led to contact resistance. This applied thermal stress and damage to the wiring and receptacle, the contact pin, and the internal bimetallic switches of the motor protection switch. Due to the thermal stress, the thermal overload and mps of the second stage tripped. Strong forces are attached to the internal wiring on the mps when the monitor hood is opened. As a result, the blade receptacle can loosen. A review for similar complaints was not required in this case. The failure pattern is known. The device history records (dhr) were reviewed. The device was found to be conforming to the specifications and released without any discrepancies. Review of the repair history was not required. Reproducing the reported failure was not required as it is a known problem. Review of the instructions for use (ifu) and the service manual (sm) reveals that the reported error code is adequately addressed. Based on the available information, the reported failure was able to be confirmed.
 
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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 Key12022020
MDR Text Key257107586
Report Number3010850471-2021-00019
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 Received06/17/2021
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/28/2021
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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