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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 Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2021
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 the motor protection switch (mps) from an aquabplus 2000 sustained thermal damage. The biomed received an early morning call from the hemodialysis (hd) clinic when they were opening, reporting that the system was failing the t1 test when they tried turning it on. The biomed said there was an error on stage 2 (f-04-51-04) indicating that the pump was defective. When the biomed arrived onsite, they powered the system on in emergency mode 1. The machine was operable throughout the day using only the first stage. Treatments at the clinic were delayed by one hour, but there was no patient injury or harm as a result, and there were no missed treatments. The biomed discovered the damaged mps at the end of the day, when the hood was opened for further inspection. The biomed stated that one of the metal prongs on the male spade fitting of the mps was completely charred. The biomed replaced the mps and the machine still was not working. Per the biomed, the machine would turn on and the stage 2 pump would run for 2 to 3 minutes, and then it would trip the thermal overload relay. A new thermal overload relay was ordered, and after replacing this part the machine became fully operational. There was also charring found on 1 of the 3 cables that connects the power contactor to the mps. No obvious damage was found on the thermal overload relay. The biomed stated there was no evidence of any burning smell, smoke, sparks, or flames. In addition, they confirmed there were no local power grid issues in the area around the date of the event. A photo of the charred metal prong was provided for review, as were the machine data files. The replaced parts were reportedly returned for evaluation. There was no direct patient involvement associated with the reported event.
 
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 six 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 motor protection switch when the monitor hood is opened. As a result, the blade receptacle can loosen. An investigation of a returned component was not required due to the most probable failure being a known problem. 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. Based on the available information, the reported failure was able to be confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that the motor protection switch (mps) from an aquabplus 2000 sustained thermal damage. The biomed received an early morning call from the hemodialysis (hd) clinic when they were opening, reporting that the system was failing the t1 test when they tried turning it on. The biomed said there was an error on stage 2 (f-04-51-04) indicating that the pump was defective. When the biomed arrived onsite, they powered the system on in emergency mode 1. The machine was operable throughout the day using only the first stage. Treatments at the clinic were delayed by one hour, but there was no patient injury or harm as a result, and there were no missed treatments. The biomed discovered the damaged mps at the end of the day, when the hood was opened for further inspection. The biomed stated that one of the metal prongs on the male spade fitting of the mps was completely charred. The biomed replaced the mps and the machine still was not working. Per the biomed, the machine would turn on and the stage 2 pump would run for 2 to 3 minutes, and then it would trip the thermal overload relay. A new thermal overload relay was ordered, and after replacing this part the machine became fully operational. There was also charring found on 1 of the 3 cables that connects the power contactor to the mps. No obvious damage was found on the thermal overload relay. The biomed stated there was no evidence of any burning smell, smoke, sparks, or flames. In addition, they confirmed there were no local power grid issues in the area around the date of the event. A photo of the charred metal prong was provided for review, as were the machine data files. The replaced parts were reportedly returned for evaluation. There was no direct patient involvement associated with the reported event. In additional follow-up, it was confirmed that the wires from the contactor to the motor protection switch had been replaced, even though only one of them was blackened.
 
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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 Key12022106
MDR Text Key257107534
Report Number3010850471-2021-00020
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 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 Received06/29/2021
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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