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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 06/03/2021
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 thermal damage on two cables inside an aquabplus 2000. 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. The biomed said there was an error on stage 2 (f-04-51-04) indicating the stage 2 distribution pump failed. 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. There was no patient impact or involvement associated with the event. At the end of the day, the biomed contacted technical support for troubleshooting assistance. The biomed first confirmed there were no blown fuses in the local power supply. The hood was then opened for further inspection, and the biomed discovered a burnt cable (l2) from the motor protection switch (mps) to the power contactor, in stage 2. The biomed confirmed there was no burn damage on the switch itself. The biomed ordered a spare mps to have on hand. Further inspection found that the l2 cable in stage 1 was also burnt. Since stage 1 was still working, the biomed determined that the burnt cable from stage 2 caused the failure. To resolve the reported issue, the biomed replaced the burnt cables. A photo of the burnt cable from stage 2 was provided for review. The biomed did not have any photos of the cable from stage 1. It was verified that the thermal overload switch was not tripping. After replacing the burnt cables, the machine became fully operational. 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. The biomed also confirmed the machine is plugged into a ground-fault circuit interrupter (gfci) outlet. The damaged cables were available to be returned for manufacturer evaluation and the ftp machine files were provided for review.
 
Manufacturer Narrative
Plant investigation: based on the provided picture, the reported event could be confirmed. A review for similar complaints was not required in this case as the failure pattern is a known. The issue was caused by bad electrical contact which resulted in overheating of the blade receptacle and wire connection. The design of the crimp and blade receptacle will be changed in the new design. Failing to observe a cool down time after resetting the motor protection switch could have contributed to the reported event. The cooling time must be considered after a triggered motor protection switch. The device history records (dhr) were reviewed. The device was found to be conforming to the specifications and released without any discrepancies. The reported event is known and could be clearly seen on the provided picture. No sample was required as the failure pattern is known. Review of the instructions for use (ifu) revealed that the regular visual inspection is not user related. The cooling time to be observed is described in the ifu. The service manual (sm) review revealed that regular visual inspections are adequately addressed. Based on the available information, the reported failure was able to be confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported finding thermal damage on two cables inside an aquabplus 2000. 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. The biomed said there was an error on stage 2 (f-04-51-04) indicating the stage 2 distribution pump failed. 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. There was no patient impact or involvement associated with the event. At the end of the day, the biomed contacted technical support for troubleshooting assistance. The biomed first confirmed there were no blown fuses in the local power supply. The hood was then opened for further inspection, and the biomed discovered a burnt cable (l2) from the motor protection switch (mps) to the power contactor, in stage 2. The biomed confirmed there was no burn damage on the switch itself. The biomed ordered a spare mps to have on hand. Further inspection found that the l2 cable in stage 1 was also burnt. Since stage 1 was still working, the biomed determined that the burnt cable from stage 2 caused the failure. To resolve the reported issue, the biomed replaced the burnt cables. A photo of the burnt cable from stage 2 was provided for review. The biomed did not have any photos of the cable from stage 1. It was verified that the thermal overload switch was not tripping. After replacing the burnt cables, the machine became fully operational. 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. The biomed also confirmed the machine is plugged into a ground-fault circuit interrupter (gfci) outlet. The damaged cables were available to be returned for manufacturer evaluation and the ftp machine files were provided for review.
 
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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 Key12021947
MDR Text Key257107620
Report Number3010850471-2021-00016
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 07/21/2021
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 Received07/02/2021
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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